Aesthetic Method of Biological Structure Treatment by Magnetic Field

ABSTRACT

Methods for treating a patient using time varying magnetic field are described. The treatment methods combine various approaches for aesthetic treatment. The methods are focused on enhancing a visual appearance of the patient.

PRIORITY CLAIM

This application is a Continuation-in-Part of U.S. patent applicationSer. No. 15/954,783, filed Apr. 17, 2018, now pending; which is aContinuation-in-Part of U.S. patent application Ser. Nos. 15/862,410,filed Jan. 4, 2018; 15/677,371 filed Aug. 15, 2017; and 15/601,719,filed May 22, 2017; all of which are pending. Application No. 15/862,410is a Continuation-in-Part of U.S. patent application Ser. Nos.15/473,390, filed Mar. 29, 2017, now pending; and 15/860,443, filed Jan.2, 2018, now pending. Application No. 15/677,371 is aContinuation-in-Part of U.S. patent application Ser. Nos. 15/446,951filed Mar. 1, 2017 and now issued as U.S. Patent No. 9,937,358; and15/404,384 filed Jan. 12, 2017, now pending. Application No. 15/446,951is a Continuation-in-Part of U.S. Patent Application No. 15/396,073filed Dec. 30, 2016 and now abandoned; which is a Continuation-in-Partof U.S. patent application Ser. No. 15/178,455 filed Jun. 9, 2016, andnow pending; which is a Continuation-in-Part of U.S. patent applicationSer. No. 15/151,012 filed May 10, 2016, and now pending; which is aContinuation-in-Part of U.S. patent application Ser. No. 15/099,274filed Apr. 14, 2016, and now abandoned; which is a Continuation-in-Partof U.S. patent application Ser. No. 15/073,318 filed Mar. 17, 2016, andnow issued as U.S. Pat. No. 9,919,161; which is a Continuation-in-Partof U.S. patent application Ser. No. 14/951,093 filed Nov. 24, 2015, andnow abandoned; which is a Continuation-in-Part of U.S. patentapplication Ser. No. 14/926,365 filed Oct. 29, 2015 and now abandoned;which is a Continuation-in-Part of U.S. patent application Ser. Nos.14/789,658 filed Jul. 1, 2015, and issued as U.S. Pat. No. 9,636,519;and No. 14/789,156 filed Jul. 1, 2015 and now pending.

Application No. 15/862,410 claims priority to U.S. Provisional PatentApplication Nos. 62/440,912 filed Dec. 30, 2016; 62/440,936 filed Dec.30, 2016; and 62/440,940 filed Dec. 30, 2016. application Ser. No.15/473,390 claims priority to U.S. Provisional Patent Application Nos.62/440,905 filed Dec. 30, 2016; 62/440,922 filed Dec. 30, 2016; and62/357,679, filed Jul. 1, 2016. application Ser. No. 15/404,384 claimspriority to U.S. Provisional Patent Application No. 62/441,805 filedJan. 3, 2017.

All the above-listed applications are incorporated herein by referencein their entireties.

FIELD OF THE INVENTION

The present invention generally relates to methods using the influenceof magnetic and induced electric field on biological structure. Themagnetic field is time-varying and high powered therefore the method isbased on a value of magnetic flux density sufficient to induce at leastmuscle contraction. The invention proposes further to combine themagnetic field with radiofrequency, light, mechanical or pressure sourcein order to provide an apparatus for improved treatment.

BACKGROUND OF THE INVENTION

Aesthetic medicine includes all treatments resulting in enhancing avisual appearance and satisfaction of the patient. Patients want tominimize all imperfections including body shape and effects of naturalaging. Indeed, patients request quick, non-invasive procedures providingsatisfactory results with minimal risks.

The most common methods used for non-invasive aesthetic applications arebased on application of mechanical waves, e.g. ultrasound or shock wavetherapy; or electromagnetic waves, e.g. radiofrequency treatment orlight treatment, such as intense pulsed light or laser treatment. Theeffect of mechanical waves on tissue is based especially on cavitation,vibration and/or heat inducing effects. The effect of applications usingelectromagnetic waves is based especially on heat production in thebiological structure. However the currently used treatment methods areused separately.

A mechanical treatment using mechanical waves and/or pressure were usedfor treatment of cellulite or adipose cells. However, mechanicaltreatment includes several drawbacks such as risk of a panniculitisand/or non-homogenous result.

A thermal treatment is applied to the patient for enhancing a visualappearance of the skin by e.g. increasing production of collagen and/orelastin, smoothing the skin or reduction of cellulite and/or adiposecell. However, thermal treatment includes several drawbacks such as riskof overheating a patient or even causing a thermal damage to thepatient, risk of a panniculitis and/or non-homogenous result.

The mechanical and/or the thermal treatment is not able to provideenhanced visual appearance of a muscle, e.g. muscle shaping, toningand/or volumization effect. Mechanical treatment and/or the thermaltreatment includes several drawbacks such as risk of a panniculitis,non-homogenous result and others.

Current magnetic methods are limited in key parameters which do notallow satisfactory enhancement of visual appearance. As a result, newmethods are needed to enhance the visual appearance of the patient.

Existing devices have low efficiency and they waste energy, which limitstheir use. Eddy currents induced within the magnetic field generatingdevice create engineering challenges. Existing devices contain magneticfield generating devices which are made of metallic strips, electricwires or hollow conductors. Since the therapy requires large currents,significant losses are caused by induced eddy currents within themagnetic field generating device. Eddy currents lead to production ofunwanted heat and therefore there is need to sufficiently cool themagnetic field generating device. Also, the energy source must beprotected during reverse polarity of resonance. This requires usingprotective circuits which consume significant amounts of energy. Skintissue is composed of three basic elements: epidermis, dermis andhypodermis or so called subcutis. The outer and also the thinnest layerof skin is the epidermis. The dermis consists of collagen, elastictissue and reticular fibers. The hypodermis is the lowest layer of theskin and contains hair follicle roots, lymphatic vessels, collagentissue, nerves and also fat forming a subcutaneous white adipose tissue(SWAT). The adipose cells create lobules which are bounded by connectivetissue, fibrous septa (retinaculum cutis).

Another part of adipose tissue, so called visceral fat, is located inthe peritoneal cavity and forms visceral white adipose tissue (VWAT)located between parietal peritoneum and visceral peritoneum, closelybelow muscle fibers adjoining the hypodermis layer.

The currently used aesthetic applications don't provide any treatmentcombining the effect of time-varying magnetic field treatment andconventional treatment method, e.g. treatment by thermal treatmentand/or mechanical treatment. The currently used thermal treatmentincludes many adverse events such as non-homogenous temperaturedistribution, panniculitis, insufficient blood and/or lymph flow duringand/or after the treatment. Additionally several adverse event such aspanniculitis may occur after the treatment. Further the treatment may bepainful so that a topical anesthetic is recommended.

The development of new aesthetic treatment methods providing improvedresults in shorter time periods is needed.

SUMMARY OF THE INVENTION

The present methods and devices as described below produce a timevarying magnetic field for patient treatment which better optimizesenergy use, increases the effectiveness of the treatments and provide anew treatment. The magnetic pulses may be generated in monophasic,biphasic or polyphasic regimes. In a first aspect, the device has one ormore magnetic field generating devices; a switch; an energy storagedevice and a connection to an energy source. The magnetic fieldgenerating device may be made of wires, more preferably insulated wireswherein a conductor diameter is less than 20 mm, preferably less than 10mm, more preferably less than 3 mm, even more preferably less than 0.5mm and the most preferably less than 0.05 mm. Smaller diameter andindividual insulation of the wires significantly reduces self-heating ofthe magnetic field generating device and therefore increase efficiencyof magnetic treatment device. The magnetic field generating device maybe flexibly attached in a casing of device. The casing may comprise ablower or blowers which ensure cooling of the magnetic field generatingdevice.

The present methods provide new aesthetic applications for focusedremodeling of the patient's body. The magnetic field generating deviceof the magnetic treatment device may be flexibly attached to casing ofthe device. The blower or blowers may be arranged to blow air on bothsides of magnetic field generating device. Optionally, the magneticfield generating device may be a flat type magnetic field generatingdevice.

The new magnetic treatment methods may improve a muscle of the patient.Further the new magnetic treatment method enables improved treatmentresults. Alternatively the magnetic treatment may provide pain reliefand/or myorelaxation effect to the patient.

The method of treating a biological structure uses a combination ofnon-invasive methods for enhancing human appearance. The inventionutilizes electromagnetic field. Methods may be used for targetedremodeling of adipose tissue, focused treatment of cellulite, bodycontouring, skin tightening or skin rejuvenation. The invention relatesto focused heating of the target tissue by electromagnetic waves,whereas the effect of focused heating of the target tissue is amplifiedby the effect of a magnetic treatment.

The magnetic treatment induces the muscle contraction at higherrepetition rates and the contraction is stronger. Therefore thetreatment is more efficient for reducing the number and/or volume ofadipocytes and enhancing the visual appearance of the treated bodyregion via targeted muscle contraction. Further the temperaturehomogeneity of is improved. Additionally, strong muscle contractions athigher repetition rates cause mechanical movement of all the layers inproximity of the contracted muscle. The methods therefore causeremodeling and/or neogenesis of the collagen and elastin fibers.

The methods enable new treatments by magnetic and/or electromagneticfield. The repetition rate of the magnetic field is in the range of 1 to300 Hz with high magnetic flux density up to 7 Tesla (equivalent to70000 Gauss). The frequency of the electromagnetic field is 13.56 or40.68 or 27.12 MHz or 2.45 GHz.

On the other hand, a combination with a magnetic treatment method mayenhance the visual appearance of the muscle and/or other soft tissuesuch as skin or adipose tissue, including increase of apoptotic index.

The methods enable combined treatment using different treatment methodssuch as magnetic and/or conventional treatment methods. The combinationof different treatment methods provide a complex treatment method forfocused treatment of a treated body region.

The present methods provide combined treatment using influence ofmagnetic treatment and mechanical treatment by shock waves, ultrasoundwaves, acoustic waves and/or pressure application. The mechanicaltreatment may induce mechanical damage to the treated biologicalstructure and/or tissues. Ultrasound waves may heat adipose cells,dermis, hypodermis or other target biological structure. Ultrasoundwaves may also induce a cavitation.

The present methods and devices may include a handheld applicator, formanual and precise treatment of tissue, particularly of uneven areas,and scanning unit providing automated or manual positioning of theoptical spot created by the optical waves (for example light) on thetissue of a subject for homogenous treatment of large areas of tissue.In some embodiments, the handheld applicator may be connected to thescanning unit by an attaching mechanism which in turn provides thehandheld applicator with optical treatment. The handheld applicator mayapply optical waves onto the tissue of the subject to be scanned duringtreatment.

Present method and devices may also include sensors configured tomeasure various parameters of the scanning unit and the subject tissue.Based on the information from the at least one sensor a controllerconnected to scanning unit may change parameters of the opticaltreatment system and method, including but not limited to the opticaloutput, the duration of treatment, the optical spot size or shape, thescanning speed or direction of movement of the optical spot, thewavelength or wavelengths of the optical waves, the frequency, oroptical flux density. Such a change may provide more homogenoustreatment or may protect the patient from discomfort or harm.

The present method provides combined treatment using magnetic treatmentand thermal treatment. A combination of heating/cooling may cause anincrease in apoptotic index, increase in muscle thickness, apoptosisand/or necrosis of the target biological structure such as adiposecells. Remodeling of the target biological structure is more significantand treatment duration is reduced. Potential risks for the patientassociated with single treatment methods are avoided. Further the sideeffects such as swelling and/or inflammation are reduced and/oreliminated.

Although methods of the present invention may be described herein as asequence of steps in a particular order, it is understood that, unlessexplicitly stated otherwise, the steps of any methods of the presentinvention may alternatively be performed in a different order. In someembodiments, some or all of the steps of a method of the presentinvention may be repeated.

GLOSSARY

Conventional non-invasive and/or invasive aesthetic treatment methodsrefer to aesthetic applications based on application of mechanicalwaves, e.g. acoustic wave, ultrasound or shock wave therapy; orelectromagnetic waves, e.g. radiofrequency or diathermy treatment orlight treatment, such as intense pulsed light or laser treatment; ormechanical treatment, e.g. positive or negative pressure, rollerball,massage etc.; or thermal treatment, e.g. cryotherapy; or electrotherapymethod; or mesotherapy method and or any combination thereof.

Thermal treatment refers to treatment by heating or cooling, e.g. acryotherapy treatment.

Mechanical treatment refers to treatment methods using applying apressure such as positive or negative; applying mechanical waves such asshock waves, ultrasound waves or vibration.

Biological structure is at least one neuron, neuromuscular plate, musclefiber, adipose cell or tissue, collagen, elastin, pigment or skin.

Remodeling target biological structure refers to reducing the numberand/or volume of the adipocytes by apoptosis and/or necrosis, cellulitetreatment, body shaping and/or contouring, muscle toning, skintightening, collagen treatment, skin rejuvenation, wrinkle removing,reducing stretchmarks, breast lifting, buttock lifting, buttockrounding, buttock firming, lip enhancement, treatment of vascular orpigmented lesions of the skin or hair removing.

Body region includes muscle or muscle group, buttocks, saddlebags, lovehandles, abdomen, hips, thighs, arms, limb and/or any other tissue.

Muscle includes at least one of muscle fiber, muscle tissue or group,neuromuscular plate or nerve innervating the at least one muscle fiber.

Deep muscle refers to a muscle that is at least partly below superficialmuscles and/or to the muscle that is covered by the thick layer of othertissue, e.g. mostly adipose tissue and/or the skin, with thickness 0.5,1, 2, 3, 4, 5 or more centimeters.

Adipose tissue refers to at least one lipid rich cell, e.g. adipocyte.

Bolus refers to a layer of fluid material, e.g. water or fluid solutionof ceramic particles, preferably enclosed in a flexible sac made ofbiocompatible material.

Impulse refers to a single magnetic stimulus.

Pulse refers to a period of treatment by a magnetic field of at leastone magnetic stimulus and time duration of no stimulation, i.e. timeduration between two impulses from rise/fall edge to next rise/falledge.

Repetition rate refers to frequency of firing the pulses; it is derivedfrom the time duration of a pulse.

Combined treatment refers to a combination of at least two differenttreatment methods, e.g. application of magnetic field and thermaltreatment, application of magnetic field and mechanical treatment, orapplication of magnetic field with thermal treatment and mechanicaltreatment.

Hardware panel refers to at least one hardware component used forcontrolling the optical and/or magnetic treatment. The hardware panelincludes at least one of input interface for inputting treatmentparameters by an operator and processing unit for controlling theoptical and/or magnetic treatment.

Optical waves refer to UV radiation, visible light, IR radiation, far IRradiation. Further optical waves may be coherent and/or non-coherent,monochromatic or polychromatic.

Optical waves generating device refers to laser or laser diode, lightemitting diode (LED), electric discharge source, incandescent source,fluorescent source, luminescent source, electroluminescent source etc.

Optical treatment parameter refers but not limited to the opticaloutput, treatment duration, optical spot size and shape, scanning speed,direction of the movement of the optical spot, treatment pattern, awavelength or wavelengths of the optical radiation, the frequency energyflux or the distance between the subject tissue and the scanning unit orhandheld applicator.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross section view of a magnetic field generating devicewinding.

FIG. 2 is a cross-section of a magnetic applicator.

FIG. 3a-c illustrate exemplary embodiment of an applicator.

FIG. 4a-4c illustrates a positioning arm

FIGS. 5a and 5b illustrate circuits for providing high power pulses to astimulating magnetic field generating device.

FIG. 7 is a graph showing voltage drop in the energy storage device.

FIG. 8 illustrates an exemplary treatment duty cycle

FIG. 9 is a diagram of a biological effect.

FIGS. 10a and 10b illustrate diagrams of a treatment device and/or anapplicator providing magnetic and/or mechanical treatment.

FIGS. 11a and 11b illustrate diagrams of a treatment device and/or anapplicator providing magnetic and/or thermal treatment.

FIG. 12 illustrates an exemplary embodiment of a treatment deviceincluding two circuits generating independent magnetic fields.

FIG. 13 illustrates an exemplary trapezoidal envelope.

FIG. 14 illustrates types of muscle contraction.

FIGS. 15 illustrate exemplary applications for buttock treatment.

FIG. 16 illustrates an exemplary application for abdomen treatment.

FIG. 17 illustrates a combined treatment administered by two separatedevices.

FIGS. 18a and 18b illustrate a combined treatment administered by onedevice including a plurality of applicators comprising magnetic fieldgenerating device or optical waves generating device.

FIGS. 19a and 19b illustrate a combined treatment by one deviceincluding one applicator comprising at least one magnetic fieldgenerating device and at least one optical waves generating device.

FIGS. 20a and 20b illustrate a combined treatment with optical wavesgenerating device powered by magnetic field generated by magnetic fieldgenerating device.

FIG. 21 illustrates a diagram of an exemplary device.

FIGS. 22a and 22b illustrate exemplary handheld applicators.

FIG. 23a illustrates a handheld applicator disconnected from a scanningunit.

FIG. 23b illustrates a handheld applicator connected to a scanning unit.

FIG. 24 illustrates examples of treatment patterns.

FIGS. 25a and 25b illustrate examples of a treatment area and treatmentpattern.

FIGS. 26a-26c illustrate examples of energy distribution.

FIG. 27 illustrates an example of device using negative pressure.

DETAILED DESCRIPTION

It is to be understood that the figures and descriptions of the presentinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the present invention, while eliminating,for the purpose of clarity, many other elements found in related systemsand methods. Those of ordinary skill in the art may recognize that otherelements and/or steps are desirable and/or required in implementing thepresent invention. However, because such elements and steps are wellknown in the art, and because they do not facilitate a betterunderstanding of the present invention, a discussion of such elementsand steps is not provided herein. The disclosure herein is directed toall such variations and modifications to such elements and methods knownto those skilled in the art.

The magnetic treatment device may include at least one magnetic fieldgenerating device. Alternatively the magnetic treatment device mayinclude a plurality of the magnetic field generating devices. The atleast one applicator may include at least one magnetic field generatingdevice. Alternatively at least one applicator may include the pluralityof the magnetic field generating devices.

FIG. 1 illustrates a cross section of winding of a magnetic fieldgenerating device for a magnetic treatment device. The magnetic fieldgenerating device may be constructed from litz-wire, wherein each wireis insulated separately. Each individual conductor is coated withnon-conductive material so the magnetic field generating deviceconstitutes multiple insulated wires. Unlike existing magnetic fieldgenerating device conductors, the present magnetic field generatingdevice is not made of bare wire e.g. litz-wire without insulation, orconductive tapes, conductive strips, or copper pipe with hollowinductors. The insulation of wires separately is a substantialimprovement, since this leads to a significant reduction of the inducededdy currents. Power loss due to eddy currents, per single wire, isdescribed by Equation 1 below. The small diameter of wires significantlyreduces self-heating of the magnetic field generating device andtherefore increases efficiency of the present magnetic treatment device.

$\begin{matrix}{{P_{EDDY} = \frac{\pi^{2} \cdot B_{P}^{2} \cdot d^{2} \cdot f^{2}}{6 \cdot k \cdot \rho \cdot D}},} & {{Eq}.\mspace{14mu} 1}\end{matrix}$

where: P_(EDDY) is power loss per unit mass (W·kg⁻¹); B_(p) is the peakof magnetic field (T); f is frequency (Hz); d is the thickness of thesheet or diameter of the wire (m); k is constant equal to 1 for a thinsheet and 2 for a thin wire; ρ is the resistivity of material (Ω·m); Dis the density of material (kg·m³).

The individual insulation of each wire reduces eddy currents. Theindividually insulated wires may be wound either one by one or in abundle of individually insulated wires so as to form a magnetic fieldgenerating device, which will serve as a magnetic field generator. Themagnetic field generating device provides an improvement in theefficiency of energy transfer in the LC resonant circuit and alsoreduces or eliminates unwanted thermal effects.

The magnetic field generating device may have a planar magnetic fieldgenerating device shape where the individually insulated wires may havecross-section wires with conductor diameter less than 20, 10, 5, 3, 1,0.5 or 0.05 mm. The wires are preferably made of materials with higherdensity and higher resistivity e.g. gold, platinum or copper. Thediameters of the single wires should be minimal. On the other hand thetotal diameter should be maximal because of inverse proportion betweenthe cross-section of all wires forming the magnetic field generatingdevice and the electrical resistance. Therefore the ohmic part of theheat is then lower. Eq. 2 describes power loss of the magnetic fieldgenerating device:

$\begin{matrix}{P_{R} = \frac{\rho \cdot \frac{l}{S} \cdot I^{2}}{m}} & {{Eq}.\mspace{14mu} 2}\end{matrix}$

Where: P_(R) is the power loss heat dissipation (W);≯ is the resistance(Ω·m); I is the length of wire (m); S is the surface area (m²); I is thecurrent (A) and m is 1 kg of wire material.

Total power loss is (Eq.3):

P _(TOT) =P _(EDDY) +P _(R).   Eq. 3

Where: Pror is the total power losses (W·kg⁻¹); P_(EDDY) is the powerdissipation of eddy currents (W·kg⁻¹); P_(R) is the power loss heatdissipation (W·kg⁻¹).

Dynamic forces produced by current pulses passing through the wires ofthe magnetic field generating device cause vibrations and unwantednoise. The individual insulated wires of the magnetic field generatingdevice may be impregnated under pressure so as to eliminate air bubblesbetween the individual insulated wires. The space between wires can befilled with suitable material which causes unification, preservation andelectric insulation of the system. Suitable rigid impregnation materialslike resin, and elastic materials like PTE can be also used. With themagnetic field generating device provided as a solid mass, thevibrations and resonance caused by movements of the individual insulatedwires are suppressed. Therefore noise is reduced.

The magnetic field generating device may be attached to the case of theapplicator, such as a hand held applicator of the magnetic treatmentdevice; build-in applicator in e.g. chair, bed; or stand-aloneapplicator e.g. on mechanical fixture. The hand held applicator mayinclude a display unit for controlling the magnetic treatment device.Alternatively the display unit may display treatment parameters such asa repetition rate, a magnetic flux density or lapsed time of thetreatment. The magnetic treatment device may preferably include a humanmachine interface (HMI) for displaying and/or adjusting the treatmentparameters. The HMI may include at least one button, knob, slidecontrol, pointer or keyboard. Alternatively the HMI may include atouchscreen, an audio-visual input/output device such as PC includingdisplay unit, an input unit and/or a graphical user interface.

The mechanical fixture may be rigid with the applicator hanging on therigid mechanical fixture. Alternatively the mechanical fixture may bearticulated. The mechanical fixture may include at least one joint toenable tailor made position of the applicator. The attachment may beprovided by an elastic material e.g., silicone, gum; or other flexiblemanner. Connection with the magnetic field generating device of theapplicator's casing may be ensured by several points. The severalfastening points ensure the connection of the magnetic field generatingdevice to the casing by flexible material so that the main part of themagnetic field generating device and the main part of the casing ofapplicator are spaced apart. The spacing should be at least 0.1 mm sothat air can easily flow. Alternatively the spacing may be at least 1mm, most preferably at least 5 mm to enable cooling media flow. The gapbetween the magnetic field generating device and the casing can be usedeither for spontaneous or controlled cooling. The magnetic fieldgenerating device may optionally be connected to the case of theapplicator by only one fastening point. The fastening points eliminatevibrations of wires which could be transferred to housing of theapplicator and therefore reduce noise of the magnetic treatment device.

FIG. 2 is a cross-section of the magnetic applicator which allows betterflow on the lower and upper sides of the magnetic field generatingdevice and thus more efficient heat dissipation. The magnetic treatmentdevice includes a magnetic field generating device 1, the circuit wires2 and the fastening points 3 for connection of the magnetic fieldgenerating device to the casing of the applicator (not shown). Thefastening points 3 are preferably made of flexible material however therigid material may be used as well. The fastening points 3 may belocated on the outer circumferential side of the magnetic fieldgenerating device. However, alternatively it is possible to put thesefastening points to a lower or upper side of the magnetic fieldgenerating device.

The fastening points 3 connect the magnetic field generating device tothe case of the applicator in at least one point. The fastening points 3maintain the magnetic field generating device and the main part of thecase of the applicator spaced apart so that fluid (which may be air orany liquid) can flow between them. At least one blower 4 can be placedaround the circumference of the magnetic field generating device, orperpendicular to the magnetic field generating device. The blower can beany known kind of device for directing the fluid e.g. outer air directedinto the case of the applicator. The blower may be e.g. a fan or asuction pump. This arrangement of the blower allows air to bypass themagnetic field generating device from upper and lower (patient's) sides.In still another embodiment the outer air can be cooled before directinginto the case. The blower can have an inlet placed around thecircumference of the magnetic field generating device for injecting air,to remove heat from the magnetic field generating device. A connectingtube (not shown) can ensure connection of the applicator 5 with theenergy source and/or control unit of magnetic treatment device. Theconnecting tube may also contain a conduit of the fluid, e.g. apressurized air.

Alternatively the magnetic field generating device may be attached tothe casing of the applicator via a circular rigid member encircling themagnetic field generating device. The outer circumference of thecircular rigid member may be attached to the casing of the applicator.The magnetic field generating device may be flexibly attached to theinner circumference of the circular rigid member by at least oneattaching point. Alternatively the magnetic field generating device maybe attached to the circular member by its entire circumference.

The arrows 6 indicate the air flow through the applicator 5. Thisarrangement of the blower allows the air to bypass the magnetic fieldgenerating device from upper and lower (patient's) side. Outlet may bepreferably placed on upper side of the casing. The outlet may include aplurality of holes enabling unimpeded removing of heated cooling mediafrom the casing of the applicator. By placing the blower around thecircumference of the magnetic field generating device instead of on thetop/below the magnetic field generating device, the blower 4 does notinterfere with the magnetic flux peak and therefore its lifespan andreliability is increased.

FIG. 3a is an illustrative embodiment of a casing of the magneticapplicator. The overview drawing contains casing itself 7, which mightcontain an outlet 8 preferably placed on upper side of the casing 7. Theapplicator may further include a handle 49 on the upper side of thecasing. The handle 47 may be used for manual positioning the applicator.A connecting tube 9 may not only ensure connection of the applicatorwith the energy source and/or control unit of magnetic treatment device,but also connection to a source of the fluid; however the conduit of thefluid 10 may also be connected separately.

In an alternative embodiment cooling may be provided by a member usingthermoelectric effect, e.g. a Peltier cooler. Alternatively, cooling maybe provided by Stirling engine cooling system.

FIG. 3b illustrates a side view of an exemplary embodiment of concaveapplicator. The applicator of concave shape includes a handling member49 as a concavity 50 of the applicator. The concavity may enableinserting a positioning member such as a length adjustable belt. Thehandling member 49 may be also used for manual positioning of theapplicator. The handling member 49 may be preferably is a center of theapplicator.

FIG. 3c illustrates a top view of the concave applicator. The applicatormay preferably include a marker 51 above the center of the magneticfield generating device. The marker 51 may enable comfortablepositioning the applicator by the operator. The marker may be a recessin a surface of the casing. Alternatively the marker may be differentsurface cover. Alternatively the upper side of the casing may includetwo colors. One color may be over the magnetic field generating deviceto enable correct positioning of the applicator. The rest of theapplicator may be of different color. The color may be interpreted as apaint reflecting a specific wavelength and/or spectra.

The applicator may be made of biocompatible material enabling highhygiene standard, e.g. a fluidly sterilizable plastic.

A static position of the at least one applicator may be provided by apositioning member. The positioning member may be e.g. an arm or anadjustable flexible belt. The positioning member may ensure tightattachment of the applicator within the proximity of the body region, oralternatively, direct contact with the patient. The direct contact withthe patient may include direct contact with the skin of the patient,i.e. the applicator including the magnetic field generating devicetouching the patient's skin or the applicator contacting the patient'sskin through a garment or any spacing object. Alternatively, thepositioning member may hold the applicator including the magnetic fieldgenerating device in no contact with patient's skin.

The positioning member may include a buckle for adjusting the length ofthe belt. The applicator may be placed within predefined locations ofthe belt. Alternatively the applicator may be shaped to be moveablealong the positioning member, e.g. the shape of the applicator may bepreferably concave, e.g. V-shaped or U-shaped. The positioning membermay be inserted itself into the concavity of the applicator. Theposition of the applicator may be adjusted by limited movement along thepositioning member because the positioning member may be used as guidingmember. However, the applicator may not be fixed to a particular staticposition. The position of the applicator may be dynamically adjustedduring the treatment following the patient's needs. The position of theapplicator may be adjusted manually by the operator, or automatically bythe treatment device. In one exemplary embodiment a plurality ofapplicators may be used for treating larger body regions, e.g. buttocks,abdomen or thigh.

The positioning arm may include a plurality of moveable members whichmay be articulated. A motion of the at least one moveable member may betranslational and/or rotational. The positioning arm may include atleast on joint providing at least one degree of freedom for thepositioning arm. In more preferred embodiment the positioning armincludes a plurality of degrees of freedom, e.g. two, three or more. Anexample of such positioning arm may be an open kinematic chain includingat least two, more preferably four, even more preferably six degrees offreedom. A fixed frame of the open kinematic chain may be a body of themagnetic treatment device. An endpoint of the kinematic chain may be anapplicator and/or a magnetic field generating device.

FIG. 4a illustrates an exemplary embodiment of the treatment device 11including a positioning arm 12 for positioning the applicator (notshown). The treatment device 11 may include wheels 14 for moving thetreatment device. The wheels may be propelled.

FIG. 4b illustrates the positioning arm 12 including moveable links 15connected by joints 16 enabling two, four most preferably six degrees offreedom. Three of these joints may be locked by a locking mechanism suchas a screw mechanism.

The positioning arm 12 is attached to the treatment device 11 at firstend of the positioning arm 17 (not shown).

The positioning arm further includes a hollow sleeve 18 at the secondend 19. The sleeve 18 includes a gap 20 for removably attaching theapplicator 13 to the positioning arm 12.

The positioning arm may include a member for guiding the connectingtube.

FIG. 4c illustrates a hand-held applicator 13 which may be removablyattached to the positioning arm 12. The connection of the hand-heldapplicator 13 to the positioning arm is enabled by a locking mechanism.The hand-held applicator 13 includes a latching member 22 biased by aresilient member. The latching member 22 is adapted to fit the gap 20 inthe hollow sleeve 18 at the second end of the positioning arm. Theapplicator 13 is attached to the positioning arm 12 by inserting theapplicator 13 into the sleeve 18 and locking the latching member 22 inthe gap 20. Applicator may be removed by pressing the latching memberand pulling the applicator from the sleeve.

Still other embodiments of positioning member may be found inprovisional U.S. patent application No. 62/357,679 incorporated hereinby reference.

FIGS. 5a and FIG. 5b illustrate exemplary embodiments of circuits forproviding high power pulses to the stimulating magnetic field generatingdevice. The proposed circuits include charging the energy storage devicefrom the energy source, repetitively switching the switching device, anddischarging the energy storage device to the magnetic field generatingdevice in order to generate the time-varying magnetic field. The energysource or the switching device, or alternately both the energy sourceand the switching device, may be regulated by a control unit. Thecontrol unit may also provide regulation and maintenance of thetreatment parameters described in this document.

Referring to FIG. 5a , the circuits for providing high power pulses tothe stimulating magnetic field generating device contain a seriesconnection to the switch 23 and the magnetic field generating device 24.The switch 23 and the magnetic field generating device 24 together areconnected in parallel with an energy storage device 25. The energystorage device 25 is charged by the energy source 26 and the energystorage device 25 then discharges through the switching device 23 to themagnetic field generating device 24.

During second half-period of LC resonance, the polarity on the energystorage device 25 is reversed in comparison with the energy source 26.In this second half-period, there is a conflict between energy source26, where voltage on positive and negative terminals is typicallythousands of Volts. The energy storage device 25 is also charged to thepositive and negative voltage generally to thousands of Volts. As aresult, there is in the circuit, consequently, twice the voltage of theenergy source 26. Hence the energy source 26 and all parts connected inthe circuit are designed for a high voltage load. Therefore, theprotective resistors and/or protection circuitry 27 must be placedbetween energy source 26 and energy storage device 25. Either the energysource 26 or the switch 23, or alternately both the energy source 26 andthe switch 23 may be regulated by a control unit 115. The control unit115 may enable regulating and/or adjusting the parameters described inthis document in order to generate time varying magnetic field for thetreatment. The regulation may be done by the preset protocol or by theoperator/end user of the device through HMI.

FIG. 5b shows a circuit for providing high power pulses for improvedfunction of the magnet treatment device. The magnetic field generatingdevice 28 and an energy storage device 29 are connected in series anddisposed in parallel to the switch 30. The energy storage device 29 ischarged through the magnetic field generating device 28. To provide anenergy pulse, controlled shorting of energy source 31 takes placethrough the switch 30. In this way the high voltage load at theterminals of the energy source 31 during the second half-period of LCresonance associated with known devices is avoided. The voltage on theterminals of energy source 31 during second half-period of LC resonanceis a voltage equal to the voltage drop on the switch 30. Either theenergy source 31 or the switch 30, or alternately both the energy source31 and the switch 30, may be regulated by a control unit 115. Thecontrol unit 115 may enable regulating and/or adjusting the parametersdescribed in this document in order to generate time varying magneticfor the treatment. The regulation may be done by the preset protocol orby the operator/end user of the device through HMI.

A capacitance of the energy storage device may be in the range of 5 nFto 100 mF, preferably in the range of 25 nF to 50 mF, more preferably inthe range of 100 nF to 10 mF, even more preferably in the range of 1 μFto 1 mF, most preferably in the range of 5 to 500 μF.

The energy storage device may provide a voltage of at least 100, 250,500, 1000, 1500, 2500 V or more.

The energy storage device may provide a current pulse discharge at least100, 250, 500, 750, 1000, 1500, 2000 A or more.

The switch 30 l can be any kind of switch such as diode, MOSFET, JFET,IGBT, BJT, thyristor or their combination. Depending on the type ofcomponent the load of energy source 31 is reduced to a few Volts, e.g.,1-10 volts. Consequently, it is not necessary to protect the energysource 31 from a high voltage load, e.g., thousands of Volts. The use ofprotective resistors and/or protection circuits is reduced oreliminated. The present designs simplify the circuits used, increaseefficiency of energy usage and provide higher safety.

An inductance of the magnetic field generating device may be up to 1 H,or in the range of 1 nH to 1 H, or in the range of 1 nH to 50 mH,preferably in the range of 50 nH to 10 mH, more preferably in the rangeof 500 nH to 1 mH, most preferably in the range of 1 to 500 μH.

FIG. 6 illustrates a floor projection of an exemplary embodiment ofcircular planar magnetic field generating device. The magnetic fieldgenerating device is characterized by dimensions including outerdiameter D; inner diameter d; inner radius r and outer radius R. Themagnetic field generating device is further characterized by areas A1and A2.

The area A1 is associated with dimensions r and d. The area A1 includesno winding. The area A1 may be represented by a core. The core may bepreferably air core.

The area A2 is associated with dimensions R and D. The area A2 includesthe magnetic field generating device itself, i.e. windings of themagnetic field generating device.

The dimension r may be in the range of 1 to 99% of the dimension R, morepreferably in the range of 2 to 95% or 3 to 80% of the dimension R, evenmore preferably in the range of 4 to 60% or 6 to 50% of the dimension R,most preferably in the range of 7 to 40%. The dimensions of r and R maybe used for achieving convenient shape of the generated magnetic field.

In an exemplary embodiment the magnetic field generating device diameterD is 100 mm and the dimension r is 10% of the dimension R. In thatexemplary case the dimension R is 50 mm and the dimension r is 5 mm.

The area A2 includes a plurality of windings. One winding may include aplurality of wires, preferably insulated wires. The windings arepreferably tightly arranged, most preferably one winding touching theadjacent winding. The winding area A2 may be at least 0,99 cm². Thewinding area A2 may be in the range of 4 to 7900 cm², preferably in therange of 9 to 1950 cm², more preferably in the range of 15 to 975 cm²,most preferably in the range of 45 to 450 cm².

Alternatively the windings may include a gap between each other. The gapmay be up to 50, 25 15, 10, 5, 1, 0.5 or 0.1% of the dimension R-r.

A total magnetic field generating device surface, i.e. A1+A2, may be inthe range of at least 1 cm². The total magnetic field generating devicesurface may be up to 8000 cm², or in the range of 5 to 8000 cm²,preferably in the range of 10 to 2000 cm², more preferably in the rangeof 20 to 1000 cm², most preferably in the range of 50 to 500 cm².

The core area A1 may be in a range of 0.01% to 99% of the total magneticfield generating device surface. Alternatively the core area A1 may bein a range of 0.05% to 95%, preferably in a range of 0.5 to 90%, morepreferably in a range of 1 to 75%, even more preferably in a range of 5%to 60%, most preferably in a range of 10% to 40% of the total magneticfield generating device surface.

A total weight of the magnetic field generating device may be in a rangeof 1 gram to 50 kg. The total weight of the magnetic field generatingdevice may be preferably in a range of 10 gram to 25 kg, more preferablyin a range of 0.1 to 15 kg, even more preferably in a range of 0.5 to 10kg, most preferably on the order of kilograms, for example 1 kg, 2 kg, 3kg, 5 kg, or more.

A magnetic fluence is defined by Equation 4.

MF=B _(PP) ·A _(MFGD)   Eq. 4

where: MF is magnetic fluence [T·cm²]; B_(PP) is maximal peak to peakmagnetic flux density generated by the magnetic field generating device[T]; AMFGD is area of the magnetic field generating device [cm²].

The magnetic field generating device may generate the time-varyingmagnetic field of the magnetic fluence in a range of 5 to 60000 T·cm²,or in a range of 60 to 60000 T·cm², or in a range of 70 to 60000 T·cm²,or in a range of 5 to 40000 T·cm², preferably in the range of 70 to20000 T·cm², more preferably in the range of 75 to 15000 T·cm², evenmore preferably in the range of 80 to 2000 T·cm² or up to 60000 T·cm².

A winding magnetic fluence is defined by Equation 5.

WMF=B _(PP) ·A ₂   Eq. 5

where: WMF is winding magnetic fluence [T·cm²]; B_(PP) is maximal peakto peak magnetic flux density generated by the magnetic field generatingdevice [T]; A₂ is winding area of the magnetic field generating device[cm²].

The magnetic field generating device may generate the time-varyingmagnetic field with the winding magnetic fluence of at least 5, 10, 15or 20 T·cm², or in a range of 5 to 40000 T·cm², or in a range of 40 to40000 T·cm², or in a range of 40 to 20000 T·cm², preferably in the rangeof 50 to 10000 T·cm² or in a range of 75 to 7500 T·cm², more preferablyin the range of 100 to 5000 T·cm² or 150 to 2750 T·cm², even morepreferably in the range of 200 to 2000 T·cm² or 275 to 1500 T·cm², or upto 40000 T·cm².

According to some embodiments, the magnetic field generating device mayround, circular, oval, square, rectangular or any other shape.Alternatively, the magnetic field generating device may be a solenoid.

FIG. 7 shows an exponential voltage drop in the energy storage device.Energy savings during time-varying magnetic therapy may be characterizedby reduced voltage drop in the energy storage device between the first,second and subsequent maximums of the resonant oscillation. Themagnitude of the individual voltage oscillations is exponentiallydampened up to establishing the energy balance. This allows increasingthe maximum possible frequency/repetition rate of magnetic pulses, sincethe frequency/repetition rate is dependent on the speed with which it ispossible to recharge the energy storage device. Since the energy storagedevice is recharged by the amount of energy loss during the previouspulse, it is possible to increase the frequency/repetition rate of thedevice up to hundreds of magnetic pulses per second without the need toincrease the input power. The voltage drop between any of the successiveamplitudes is not higher than 45, 40, 30, 21, 14 or 7%.

The device may include at least one sensor for measuring operationparameter such as voltage, current or phase. The measured operationparameter may be used for determining a value of the generated heat. Thegenerated heat may be used for prediction of a temperature of themagnetic treatment device. Typically the method may be used fortreatment planning and/or to predict the temperature of the applicatorand/or the part of the magnetic treatment device which is the mostsusceptible to overheating such as wires and/or resistors etc.

The magnetic treatment device may be described by the transition thermalcharacteristic (TTC). The TTC may be determined by experimentalmeasurement during standard ambient conditions such as temperatureand/or pressure, or it may be a mathematical model based on technicaland/or electric specifications of all components of the magnetictreatment device. TTC characterizes the temperature dependence of themagnetic treatment device on heat. TTC is established by themanufacturer as the factory settings.

The value of generated heat determined by the recited application of theinvention corresponds with the treatment parameters. The temperatureevolution of the magnetic treatment device is dependent during thetreatment on at least one of treatment parameters, actual temperature ofthe magnetic treatment device, ambient temperature, cooling mediumtemperature, cooling medium flow or heat dissipation.

A calculation algorithm is set up to operate at least TTC and treatmentparameters to determine the temperature of the magnetic treatment deviceduring the treatment. The maximal temperature of the magnetic treatmentdevice is limited and predetermined. However, in alternative applicationthe maximal temperature of the magnetic treatment device may be adjustedby the operator. The maximal temperature may be considered to be safefor the patient.

The magnetic treatment device may include a system for monitoring apresence of the patient on a patient support. The patient support mayinclude at least one pressure sensor such as a load cell, anaccelerometer, an optical sensor, or a capacitive sensor. Alternativelythe sensor may be a camera placed a predetermined distance from thepatient support. The sensor may measure one or more physical quantities.The control unit of the magnetic treatment device may evaluate one ormore signals from the sensor. The control unit may start and/or stop thetreatment in response to a signal value from the pressure sensor.

The magnetic treatment device may include a plurality of pressuresensors. The plurality of pressure sensors may enable determination ofat least a position of the patient on the patient support. The controlunit may adjust a position of the magnetic field generating device inthe patient support to improve a treatment effect. Alternatively thecontrol unit may notify an operator to reposition the patient.

The device may be used for treatment/successive treatments in continual,interrupted or various duty cycle regime. The treatment duty cycle maybe higher than 10%, which means interrupted regime with the ratio up to1 active to 9 passive time units. The ratio may possibly change duringthe therapy. In the preferred application the treatment duty cycle maybe at least 15, 20, 25, 40, 50, 75, 85 or 90%.

In an exemplary embodiment the magnetic treatment device include a mainbody of the magnetic treatment device and a plurality of applicators.Preferably two applicators may be used. The main body of the magnetictreatment device may include a connection to a power grid and twoindependent circuits for generating the magnetic field. Each independentcircuit may include a power source, a switching device, an energystorage device and a magnetic field generating device. The magneticfield generating device may be preferably externally from the main bodyof the magnetic treatment device, i.e. in the applicator. Eachapplicator may include one magnetic field generating device.

Alternatively the magnetic field generating devices may generate thetime-varying magnetic field simultaneously. The magnetic field generatedsimultaneously may interfere. Alternatively the plurality of magneticfield generating devices may generate the magnetic field in differenttime, e.g. sequentially.

FIG. 12 illustrates an exemplary embodiment of the magnetic treatmentdevice including two independent magnetic field generating circuits(dotted lines). Magnetic field generating circuit 52 may include powersupply 53; switching device 54; energy storage device 55 and magneticfield generating device 56. Magnetic field generating circuit 57 mayinclude power supply 58; switching device 59; energy storage device 60and magnetic field generating device 61.

Alternatively the magnetic field generating circuit may include aplurality of energy storage devices providing energy to a magnetic fieldgenerating device in order to enable higher energy pulse. Alternativelyat least one energy storage device may provide energy to a plurality ofmagnetic field generating devices. Alternatively both circuits mayinclude common power supply.

Circuit 52 may generate the time-varying magnetic field independently onCircuit 57. The magnetic treatment device may generate the magneticfield by one circuit while the second circuit is being turned off, i.e.Circuit 52 may generate the magnetic field while Circuit 57 is turnedoff or Circuit 57 may generate the magnetic field while Circuit 52 isturned off.

Alternatively Circuit 52 may generate the magnetic field of equaltreatment parameters as the magnetic field generated by Circuit 57. Bothcircuits may be set up individually or synchronously.

Alternatively Circuit 52 may generate magnetic field of treatmentparameters different from magnetic field generated by Circuit 57.

FIG. 8 illustrates an exemplary treatment duty cycle of 10% while theexemplary repetition rate is 10 Hz. An active treatment (e.g. train ofpulses) lasts for a period T1. Active treatment period may be called atrain. T1 lasts 2 s. Hence the target biological structure is treated by20 magnetic pulses. Passive treatment lasts for a period T2. T2 lasts 18second. The period T1 is repeated after T2. In this exemplary treatmentthe period including active and passive period lasts 20 seconds. Activetreatment followed by passive treatment may be called a burst, i.e. theburst includes a train and a period of no magnetic field applied to thepatient. Time of burst equals to T1+T2. The train includes a pluralityof pulses, i.e. at least two pulses. The bursts may be repetitivelyapplied to the patient. The burst repetition rate may be in a range of100 Hz to 0.01 Hz, more preferably in a range of 50 Hz to 0.02 Hz ormost preferably in a range of 10 Hz to 0.05 Hz.

An exemplary application of a burst repetition rate of 4 Hz may be thetime-varying magnetic field applied to the patient with a repetitionrate of 200 Hz and with a treatment duty cycle of 50% in trains lasting125 ms; i.e. the train includes 25 pulses. An alternative exemplaryapplication of a burst repetition rate of 6/min may be the time-varyingmagnetic field applied to the patient with a repetition rate of 1 Hz andwith a treatment duty cycle of 30% in trains lasting 3 s; i.e. the trainincludes 3 pulses.

The device enables operation defined by the peak to peak magnetic fluxdensity on the magnetic field generating device surface at least 3 T,more preferably at least 2.25 T, most preferably at least 1.5 T atrepetition rates above 50 Hz, more preferably at repetition rates above60 Hz, even more preferably at repetition rates above 70, mostpreferably at repetition rates above 80 Hz with treatment/successivetreatments lasting several seconds or longer, for example, for at least5, 10, 30, 60, 120 or 240 seconds, or longer. The total powerconsumption is below 1.3 kW and the width of pulses is in the range ofhundreds of μs.

The device enables achieving repetition rates above 100 Hz, morepreferably repetition rates above 150 Hz, most preferably repetitionrates above 200 Hz with the magnetic flux density providing atherapeutic effect on neurons and/or muscle fibers and/or endocrinecells (e.g. at least muscle contraction, action potential in cell).Based on achievement of repetition rates in order of few hundreds thedevice also enables assembling the magnetic pulses into the variousshapes (e.g. triangular, rectangular, exponential), with the shapewidths from 6 ms to several seconds or longer.

The device may enable a continual treatment and continual magnetictreatment where the set of the magnetic flux density andfrequency/repetition rate of magnetic pulses does not lead to exceedingof the operating temperature 60° C., preferably 56° C., more preferably51° C., even more preferably 48° C. most preferably 43° C. on the casingof the device operating in an ambient temperature of 30° C. regardlessof the duration of therapy.

Alternatively the magnetic field generating device may generate a staticmagnetic field. The magnetic field generating device generating thestatic magnetic field may be e.g. permanent magnet or electromagnet. Themagnetic field generating device may be powered by a power source, atransformer and/or an energy storage device. The magnetic field may beapplied as time-varying magnetic field by movement of the magnetic fieldgenerating device. Alternatively the magnetic field generating devicemay be switched on and off.

During last few decades patient have not only wanted to be in goodhealth, they have also wanted to look well, i.e. to be well shaped,without any unattractive fat and to have a young appearance, withoutwrinkles, stretchmarks or sagging breasts. This has resulted in aprogressive evolution of invasive aesthetic methods such as surgicalremoving of fat and remodeling the human body by invasive andpotentially dangerous methods, e.g. liposuction or inserting implantsinto human body. The side effects of invasive methods may be scars,swelling or bruising. The side effects resulted in the rapid progress innon-invasive method, e.g. lipolysis or removing skin imperfections. Oneexample of the last few years may is rapid increase of patients' demandfor enhancing the visual appearance of buttocks. This has resulted in ahigher percentage of these operations by plastic surgeons.

Electric current may be induced in the treated biological structureduring pulsed magnetic treatment. Due to the high value of magnetic fluxdensity the biological structure may be targeted and treated morespecifically. A distribution of magnetic field is uniform in thebiological structure. Particles (e.g. atoms, ions, molecules etc.) inthe biological structures are influenced by the magnetic field andpermeability of a cell membrane may also increase.

Due to increased permeability of the cell membrane, the pulsed magnetictreatment may induce following effects: at least muscle contraction;reduction of adipose tissue—volume and/or number of the adipose cellsincluding increase of apoptotic index; cellulite reduction; neogenesisand/or remodeling of collagen and/or elastin fibers, i.e. collagenand/or elastin increase; skin elasticity and/or skin textureimprovement; skin tightening; waist reduction. Further magnetictreatment may improve circulation of blood and/or lymph and improvelocal and/or adipose tissue metabolism. Treatment by time-varyingmagnetic field may also cause muscle hypertrophy and/or hyperplasia;reduce diastasis recti (abdominal separation); increase fat and/or basalmetabolism; and/or reduce visceral fat.

With the present methods, factors for enhancing visual appearance of thebody include: treatment of major muscle, e.g. gluteus maximus; treatmentof deep muscle which may be enabled by high value of magnetic fluxdensity; non-contact application of magnetic flux density, it may beapplied even through clothing; stronger muscle contraction due to highervalue of magnetic flux density; higher-quality of muscle targeting;treatment may not be influenced by small movements during treatment;treatment time duration may be shortened due to high value of magneticflux density and/or higher repetition rate; no delays may occur.

It is to be understood that the method is not limited to the particularapplications and that the method may be practiced or carried out invarious ways.

Present method may be applied for enhancing the visual appearance ofbody parts including or proximate to major muscle structures. Furtherthe method may be applicable for enhancing the visual appearance ofpatients with high value of BMI. A patient with BMI of at least 18,preferably at least 25, more preferably at least 30, most preferably atleast 35 or more may be preferably treated by the recited methods. Athickness of patient's SWAT and/or VWAT may be at least 0.1, 0.5, 10,15, 25, 50, 75, 100 mm or more. The patient may be preferably healthywithout any life-threatening conditions such as circulatory systemdisease, e.g. deep vein thrombosis. The present method is not limited tothe application of the treatment to major muscle. Muscles other thanmajor muscles may be treated as well.

The applicator of magnetic treatment may be placed proximate to thepatient's body. As used here, proximate to includes both contactless andin actual contact with the skin of the patient. The actual contact withthe skin of the patient may be direct contact or indirect contact.Direct contact may be the applicator contacting the skin of the patient;indirect contact may be applicator contacting the patient's skin via aspacer such as clothes, a towel or a disposable sterile cover of theapplicator. The contactless application may not touch the patient'sskin. Within a close proximity of the patient should be interpreter in arange from 0.1 to 50 mm from the patient's skin, more preferably in arange of 0.5 to 25 mm from the patient's skin, most preferably in arange of 1 to 10 mm from the patient's skin. Alternatively the magneticfield generating device is positioned at a distance in a range of 0.2 to49.9 mm, more preferably in a range of 0.6 to 24.9 most preferably in arange of 1.1 to 9.9 mm from the patient's skin. The muscles may beselectively treated and the magnetic flux density may be adjustedfollowing the patient's feeling or needs. The treatment time may beshortened due to selective treatment of the correct muscles.Additionally, due to the high value of magnetic flux density, the musclemay be treated more effectively. Further, the treatment may benon-invasive or even preferably contactless due to the high value ofmagnetic flux density. The patient may be treated without removingclothing, reducing patient discomfort. Additionally, following the highefficiency of the muscle contraction the collagen and/or elastin fibersabove the muscle structure may be remodeled, hence the visual appearancemay be enhanced.

According to exemplary application a treatment may be started by turningthe magnetic treatment device on. The applicator including a magneticfield generating device may be placed on the patient. A magnetic fluxdensity may be set up as highest magnetic flux density value acceptableby the patient. The highest magnetic flux density value acceptable bythe patient may be such a value sufficient to cause a muscle contractionand may not cause pain to the patient. Further a correct treatmentlocation may be found by an operator. The correct treatment location maybe found by moving at least one applicator over the target region of thepatient's body. Alternatively a plurality of applicators may be movedsimultaneously in order to set up the correct treatment location. Thecorrect treatment location is the location where the induced currentcauses the strongest muscle contraction. The at least one applicator maybe fixed in the correct treatment location by a positioning member suchas an adjustable belt. The belt may be flexible and/or the belt mayinclude a length adjusting member such as buckle. The treatment may bestarted, i.e. the time-varying magnetic field may be applied to thetarget region for a predetermined treatment period. The at least oneapplicator may be removed from the patient after lasting the treatmentperiod. The treatment may be ended.

The position of the patient may correspond to treated biologicalstructure and/or body region. The patient may be treated in seatedposition. Alternatively, the patient may be treated in lying position,e.g. in supine position. Treatment in lateral recumbent position may bealso applicable. Patient may be in prone position as well.

In the preferred application the treatment method may be applied to bodyregions prone to cellulite and/or prone to adipose accumulation, such asthighs, saddlebags, buttocks, abdomen, region of love handles, region ofbra fat or arm. The adipose accumulation may be influenced by numberand/or volume of adipose cells.

The magnetic field generating device may be placed in a distance up to500 mm from the skin of the patient mm. Particularly in a range of 0.01to 150 mm, more preferably in the range of 0.1 to 100 mm, even morepreferably 1 to 50 mm, most preferably in the range of 2 to 25 mm.

The magnetic treatment of the biological structure may have variousapplications for enhancing visual appearance of the contour of a bodyregion. High density magnetic field reaching such values may be used fortreatment of a muscle and/or adipose tissue, wherein the adipose tissuereduction may be achieved by reduction of number and/or volume ofadipose cells. Adipose tissue reduction may be also known as fatdisruption, reduction or removal, skin tightening body sculpting orsculpting, connective tissue improvement or adipose tissue reduction ingeneral.

Alternatively adipose tissue may be reduced and the muscle may gainstrength. These effects may be known as contouring or circumferentialreduction. Circumferential reduction refers to shape modification ofbody parts such as thighs or abdomen.

The adipose tissue reduction may be associated with increasing volume ofthe muscle. This effect may be known as core strengthening.

The adipose tissue may be reduced with improving the muscle in volumeand strength. These effects may be known as cellulite treatment, bodyshaping, body contouring, body sculpting, core shaping, muscle forming,muscle shaping, skin laxity reduction or improving aesthetic and/orvisual appearance in general.

The muscle may gain strength without adipose tissue reduction. Theeffect may be known as muscle strengthening, muscle toning or musclefirming.

The muscle may increase a volume. The effect may be known as musclevolumization or muscle tightening.

The muscle may be further improved in strength and in volume. Sucheffect may be known as muscle remodeling or stimulation, deep tissueremodeling or stimulation. This effect may be used e.g. for buttlifting.

Alternatively breast enhancement, wherein the appearance enhancementeffect may be achieved by elevation or shape modification may be caused.Further lip enhancement, wherein the lip appearance enhancement may beachieved by obtaining fuller and firmer appearance. The body region maybe reduced in overall size.

The muscle may be treated by a time-varying magnetic field applied bythe aforementioned device.

The magnetic field may treat peripheral nerves in the treated bodyregion. Alternatively, peripheral motor neurons affecting hundreds ofmuscle fibers may be selectively targeted. The muscle contraction of thewhole muscle group innervated by the specific nerve or nerve plexus maybe caused as well.

Due to high magnetic flux density of the generated magnetic fieldsupramaximal muscle contractions may occur. Supramaximal contractionscannot be voluntarily achieved. The muscle may change as it naturallyadapts to a muscle stress caused by the supramaximal contractions. Hencethe muscle strength and/or volume may increase. The muscle strengthand/or volume increase may be achieved by muscle fiber hypertrophyand/or muscle fiber hyperplasia. A muscle tension may also increase.These structural changes may be long-lasting compared to regularexercising.

Varying magnetic flux density and repetition rate resulting in themuscle contractions during the treatment may be beneficial for musclerelaxation between the muscle contractions. The treatment duty cycle maybe higher than 10%, which means interrupted regime with the ratio up to1 active to 9 passive time units. The ratio may possibly change duringthe therapy. In the preferred application the treatment duty cycle maybe at least 15, 20, 25, 40, 50, 75, 85 or 90%.

Hence effects such muscle volumization, toning, strengthening and/orremodeling may be caused.

In the methods described, the magnetic field generating device may ormay not include a magnetic core. The magnetic field generating devicemay be cooled by fluid, e.g. by air, water or oil. Total powerconsumption of the magnetic treatment device may be below 1.3 kW. Apower of the magnetic treatment device may be at least 150, 250 or 500 Wto generate a magnetic flux density sufficient to induce at least musclecontraction. Energy conversion efficiency may be at least 10, 25, 50,80% or more. The energy conversion efficiency may be enabled by theabove recited construction such as by using insulated wire, componentslayout and/or by the cooling system. A magnetic treatment device asdescribed in the U.S. patent application Ser. No. 14,789,156 or U.S.patent application Ser. No. 14,789,658 incorporated herein by reference,may be used.

The applicator for magnetic treatment may be placed proximate to thepatient's body. The magnetic flux density may be applied into the targetbiological structure. Electric current may be induced and treat theneuromuscular plate and/or the nerve innervating the at least one musclefiber. The treatment may cause at least a muscle contraction.

Furthermore, the present invention discloses the advanced approaches inaesthetic applications, e.g. for cellulite treatment and/or bodyshaping. Combined methods of treatment by electromagnetic field andtreatment by magnetic field are used. The electromagnetic field mayinclude treatment by radiofrequency, infrared or optical waves. Themagnetic treatment may be provided by permanent magnets, electromagneticdevices generating a static magnetic field or time-varying magneticdevices. In the preferred application the treatment by a pulsed magneticfield and radiofrequency treatment may be combined. However theapplication is not limited by the recited combination so the combinedmethod may include magnetic treatment and any treatment byelectromagnetic field, e.g. light treatment, IR treatment or treatmentby radiofrequency waves, e.g. microwaves, short waves or long waves. Themagnetic treatment may also be provided with thermal treatment, e.g.heating and/or cooling.

A device described in U.S. patent application Ser. No. 14/278,756incorporated herein by reference may be used for application of thepresent methods. The device may exclude the balun transformer, or thebalun transformer may be included in transmatch. The possible methods oftreatment by combined methods are described below.

Magnetic treatment in combination with radiofrequency treatment may beapplied by two independent treatment devices, e.g. one device fortreating the biological structure by radiofrequency waves and seconddevice for treating the biological structure by magnetic field. Bothdevices may have a separate applicator for treating the biologicalstructure, or one applicator may be used by at least two devices, i.e.the applicator may be modular for a plurality of devices.

The device may include at least one HF frequency generator for providingenergy for radiofrequency treatment and for providing energy formagnetic treatment. In an alternative embodiment, the device may includeat least one HF frequency generator for providing energy forradiofrequency treatment and at least one other independent frequencygenerator for providing energy for magnetic treatment. The device mayinclude plurality of applicators for providing separate radiofrequencyor magnetic treatments to the patient.

In alternative embodiment the applicator may provide a combination ofradiofrequency and magnetic treatment. In one embodiment, the applicatormay include at least one radiofrequency electrode for providingradiofrequency treatment and at least one magnetic field generatingdevice, e.g. a magnetic field generating device, for providing magnetictreatment. In another embodiment, the applicator may include at leastone electrode for providing radiofrequency treatment and at least onemagnetic field generating device providing magnetic treatment, whereinthe at least one RF source provides energy for both at least oneelectrode and at least one magnetic field generating device.

In still another embodiment the at least one RF source may provide theenergy for the at least one magnetic field generating device providingmagnetic treatment wherein the at least one magnetic field generatingdevice may be used as the at least one electrode. The essence is the fardifferent treatment frequencies which are used for RF treatment andmagnetic treatment. The magnetic field generating device in the highfrequency field is similar to the electrode. This enables the magneticfield generating device to be the electrode for radiofrequencytreatment. In the preferred embodiment a flat magnetic field generatingdevice may be used as the electrode.

The frequencies for the radiofrequency treatment may be in the range ofhundreds of kHz to hundreds of GHz, more preferably in the range of 13MHz to 3 GHz, most preferably around 13.56 or 40.68 or 27.12 MHz or 2.45GHz. The term “around” should be interpreted as in the range of 5% ofthe recited value. The impulse frequencies for the magnetic treatmentmay be in the range of hundreds of Hz to hundreds of kHz, morepreferably in the range of ones of kHz to tens of kHz, most preferablyup to 10 kHz. However the repetition rate of the magnetic impulses mayreach up to 700 Hz, more preferably up to 500 Hz, most preferably in therange of 1 to 300 Hz, e.g. at least 1, 5, 20, 30, 50, 100, 140 or 180Hz. The magnetic flux density of the magnetic treatment may be at least0.1, 0.5, 0.8, 1, 1.5, 2, 2.4 or up to 7 Tesla, or in a range of 0.1 to7 Tesla, or in a range of 0.5 to 7 Tesla, on the magnetic fieldgenerating device surface (equivalent to 70000 Gauss). Thetreatment/successive treatments may last several seconds, e.g. at least5, 10, 30, 60, 120 or 240 seconds, or longer, e.g. at least 20, 30, 45,60 minutes. The impulse duration may be in the range of 3 μs to 10 ms ormore, or alternatively 3 μs to 3 ms or alternatively 3 μs to 1 ms. Theimpulse duration may be e.g. 3, 10, 50, 200, 300, 400, 500, 625, 1000,2000 or below 3000 μs. Alternatively the impulse duration may be in therange of ms. The treatment duty cycle may be at least 1:50 (which meansmore than 2%), more preferably at least 1:40 (which means more than2,5%), even more preferably at least 1:20 (which means more than 5%),most preferably at least 1:8 (which means more than 12,5%), or at least1:4 (which means more than 25%). The magnetic treatment device may emitno radiation.

The treatment duty cycle of 1:50 should be interpreted in the sense thatone complete burst lasting a time T consists of 50 time periods T1 andthe active treatment (e.g. train of pulses) of the time-varying magneticfield is applied to the patient for one time period T1, i.e., pulses ofthe time-varying magnetic field are not applied for 49 time periods T1.The burst may be applied repetitively. In an exemplary application themagnetic field may be applied with a repetition rate 50 Hz and with atreatment duty cycle 1:50 for 10 seconds, i.e. ten pulses of themagnetic field may be applied in a train lasting 0.2 s and no magneticfield pulse is applied for 9.8 s.

The magnetic flux density applied to active sportsmen may be highercompared to magnetic flux density applied to a patient without regularexercising.

A derivative of the magnetic flux density is defined by Equation 6.

$\begin{matrix}{\frac{dB}{dt},} & {{Eq}.\mspace{14mu} 6}\end{matrix}$

where: dB is magnetic flux density derivative [T]; dt is time derivative[s].

The maximal value of the magnetic flux density derivative may be up to 5MT/s, preferably in the ranges of 0.3 to 800 kT/s, 0.5 to 400 kT/s, 1 to300 kT/s, 1.5 to 250 kT/s, 2 to 200 kT/s, 2.5 to 150 kT/s, 4 to 150kT/s, 5 to 150 kT/s. In exemplary applications the maximal value of themagnetic flux density derivative may be at least 0.3, 0.5, 1, 2.5, 3.2,5, 8, 10, 17, 30 or 60 kT/s. The value of magnetic flux densityderivative may correspond to induced current within the tissue.

The magnetic flux density derivative may be determined within entireperiod of the magnetic signal and/or in any segment of the magneticsignal.

Alternatively the treatment device may include no deep muscle diathermydevice for heating the target biological structure. The treatmentpreferably may include no electrode which may enable heating thebiological structure in contact mode.

Cellulite is an effect of skin change resulting in orange peelappearance. The cause of the cellulite is orientation of collagen fibersin so called “fibrous” septae. The fibrous septae contract and hardenover time creating a dimple effect. Additionally, blood and lymphaticvessels lack circulation due to the contraction and hardening of theseptae. The lymph flow may be blocked resulting in swelling. Anothercause of cellulite may be adipose cells protruding to dermis. Cellulitemay be treated by the recited methods.

One application of time-varying magnetic field for enhancing the visualappearance of body region may be treatment of a muscle by magnetic fluxdensity for reducing the cellulite. The magnetic flux density may bedelivered through the skin to the neuromuscular plate and/or nerveinnervating at least one muscle fiber. The electric current may beinduced in the target biological structure causing at least musclecontraction. The at least muscle contraction may cause the movement ofthe skin and all the biological structures subtending epidermis.Additionally, the at least muscle contraction may improve bloodcirculation by itself, or via the movement of the muscle in the vicinityincluding fibrous septae. Additionally, blood and/or lymph circulationmay be improved in the layers subtending epidermis since the musclecontraction may move the fibrous septae. Also local and/or adiposetissue metabolism may be improved. The muscle contraction may move theskin above the treated muscle. A displacement of the skin may be in therange of 0.1 to 150 mm, more preferably in the range of 0.5 mm 100 mm,even more in the range of 1 to 75 mm, most preferably in the range of 2to 50 mm. The skin displacement may last in the range of 0.01 to 30seconds, more preferably in the range of 0.1 to 15 seconds, even morepreferably in the range of 0.2 to 7.5 seconds, most preferably in therange of 0.5 to 5 seconds.

The lymph flow may be improved by at least muscle contraction which mayprovide effect similar to manual massage. The improved lymph flow mayimprove local metabolism and/or immune system. The improved lymph flowmay contribute to purer lymph due to faster delivery of the lymph to thelymph nodes where the lymph may be cleared.

The present method may provide a massage effect via the treatment whichmay be caused by the at least muscle contraction. Therefore the massageeffect may be achieved by contactless methods instead of manual massagetechniques or soft tissue techniques. The massage effect may improvelymph circulation.

In another aspect, improvement of functionality and/or the appearance ofthe muscle may be achieved with results similar to body exercise. Theresults may be achieved by application of high magnetic flux density tothe body region and inducing at least muscle contraction. Higher valuesof magnetic flux density applied may result in a stronger musclecontraction. The patient may feel firmer and tighter.

With the present method muscle contractions induced by the appliedmagnetic flux density may help to tone the muscle providing a moreattractive appearance. As the muscle structure is treated bytime-varying magnetic field the entire limb may be moved due to the highpower of the magnetic treatment. Nevertheless, the method is not limitedto the applications to the limbs and the method is able to treat anymuscle, e.g. gluteus maximus or any muscle/deep muscle to induce bodycontouring and/or body shaping effect and fat burn. Additionally,shortened and/or flabby muscles may be stretched. The physical fitnessof the patient may be improved as well.

The magnetic field may treat various body regions, e.g. thighs,buttocks, hips, abdomen or arms. The muscles may be shaped to enhancevisual appearance of the treated body region. The body part may obtainenhanced visual appearance of its contour.

A plurality of applicators may be used for treatment of big patientand/or for treatment of pair muscles, e.g. buttocks. Alternatively aplurality of applicators may be used for treatment of large treatmentregions such as abdomen. Two applicators may be preferably used. Eachapplicator includes at least one magnetic field generating device. Oneapplicator may be used for muscle toning.

A plurality of applicators may be placed in such position that centersof the magnetic field generating devices are in a distance in a range of2 to 80 cm, preferably in a range of 5 to 60 cm, more preferably in arange of 10 to 50 cm, most preferably in a range of 15 to 40 cm or up to100 cm.

A plurality of the magnetic field generating device may be used fortreatment of cooperating muscles in order to enhance a visual appearanceof the body region and/or to increase coordination of a movement of thebody part such as a limb or an abdomen of the patient.

One exemplary cooperating muscle set may be an agonist-antagonist pairof an arm of the patient. M. biceps brachii is responsible for forearmflexion. Oppositely, m. triceps brachii is responsible for extension ofthe forearm. Alternatively cooperating muscles responsible forflexion/extension may be represented by hamstrings, i.e. m. bicepsfemoris, and m. quadriceps femoris; or m. tibialis anterior and m.triceps surae.

Alternative exemplary cooperating muscles may be left and right m.obliquus externus abdominus; or mm. pectorales and m. latissimus dorsi.

The magnetic field may treat at least one muscle of lower limb,particularly the parts which are prone to cellulite such as thighs orsaddlebags. The time-varying magnetic field may induce at least musclecontraction in different muscle and/or muscle group. Following theposition and/or orientation of the magnetic field generating device theanterior, posterior and/or medial compartment of the thigh may betreated. The anterior compartment includes sartorius muscle, rectusfemoris muscle, vastus lateralis muscle, vastus intermedius muscle,vastus medialis muscle. Posterior compartment includes biceps femorismuscle, semitendinosus muscle and semimembranosus muscle. Medialcompartment includes pectineus muscle, external obturator muscle,gracilis muscle, adductor longus muscle, adductor brevis muscle andadductor magnus muscle.

The treatment may cause circumferential reduction of thighs. Further themuscle may obtain enhanced visual appearance, thigh may be well-shaped.Thigh contour may be enhanced as well.

The at least one surrounding body region may be treated as well, e.g.buttocks.

The applicator may be placed within proximity of the patient's treatedarea. The applicator may be fixed to the patient. Alternatively thecorrect position may be provided by a mechanic arm and/or adjustableapplicator. The applicator may be made of adhesive and/or high frictionmaterial at least on contact surface with the patient.

The magnetic field may be generated with low repetition rate of such as1 Hz for a predetermined period of time, e.g. 30 seconds, sufficient forsetting the applicator to a correct position where the treatment is mosteffective. During the period the magnetic flux density may be adjustedfollowing the patient's needs to induce muscle contraction sufficientlystrong and comfortable for the patient.

The treatment may start a treatment protocol. The treatment protocol mayinclude a set of predetermined treatment sequences consisted ofpredetermined repetition rates applied for a predetermined time periods.The sequences may be repeated and/or adjusted following the patient'sneed. The sequence may include a repetition rate in the range of 1 to100 Hz, preferably in the range of 2 to 90 Hz, more preferably in therange of 5 to 50 Hz, most preferably in the range of 10 to 45 Hz. Thesequences may last at least 30, 45, 60, 90, 120 or up to 300 seconds.

A treatment may include at least 500 magnetic pulses per one treatment,or at least 1000 magnetic pulses per one treatment are applicable aswell. Alternatively the treatment may include at least 2000, preferablyat least 5000, more preferably at least 10000, even more preferably atleast 20000 pulses, most preferably at least 50000 pulses per onetreatment. The treatment may include up to 200000 pulses per onetreatment.

Alternatively the treatment may include the only the treatment protocolwithout applying the magnetic field of low repetition rate. The correctposition of the applicator and/or adjusting the magnetic flux densitymay be adjusted during the first sequence of the treatment protocol.

In one application, the treatment may induce the same effect as muscleexercising of buttocks. During the treatment of buttocks the magneticfield may be targeted to treat of muscles shaping the buttocks, e.g.tensor fasciae latae muscle or at least one of gluteal muscles: maximus,medius or minimus. In one preferred application all three glutealmuscles may be treated. Further other muscles may be treated, e.g.abdominal muscles, spinal muscles and/or thoracic muscles. By thecomplex treatment and muscle contraction in the body region the treatedmuscles may be strengthened, toned, the cellulite may be reduced anddimples may be removed. Buttocks and even the patient's figure may beenhanced in visual shape appearance and may become more attractive.Buttocks become well-shaped, round, firm, well-trained, toned, smoother,tight and lifted. The complex treatment may reduce hips, make perfectround and lifted buttocks, increasing the self-confidence of the patient

The treatment may be more efficient than standard workout in fitnesssince the fitness machines strengthen only the isolated muscles. Theresults may be achieved in very short-time periods with minimal time oftreatment. Without being limited, it is believed that the exercising ofthe gluteus medius may reduce the volume of the buttocks; exercising ofthe gluteus maximus may shape and/or lift the buttocks; exercising ofthe gluteus minimus may lift the buttocks.

In the preferred application the magnetic treatment may be combined withother treatment methods using different approaches, e.g. conventionalnon-invasive treatments. The combined treatment may be applied to thesurroundings tissues around buttocks to reduce the cellulite around thebuttocks and enhance the shape of the enhanced appearance of thebuttocks. The surrounding tissues may be represented by e.g. abdomen,love handles, thighs or saddle bags.

The magnetic field may treat at least one muscle responsible forsilhouette of the body. The time-varying magnetic field may induce atleast muscle contraction in different muscle and/or muscle groupresponsible for silhouette in the region of abdomen, love handles and/orbra fat. Following the position and/or orientation of the magnetic fieldgenerating device rectus abdominis muscle may be treated. Alternativelylatissimus dorsi muscle, abdominal internal oblique muscle, abdominalexternal oblique muscle, transverse abdominal muscle and/or pyramidalismuscle may be treated by the time-varying magnetic field.

The treatment may cause circumferential reduction in the region ofbelly, hips and/or love handles. Alternatively the treatment may tightenat least one of these body parts. Further the muscles may obtainenhanced visual appearance, belly may be well-shaped. Repetitiveapplication may even reach in a six-pack look. The at least onesurrounding body region may be treated as well, e.g. buttocks.

The magnetic field may treat at least one muscle of upper limb,particularly the parts which may be prone to cellulite such as arm. Thetime-varying magnetic field may induce at least muscle contraction.Following the position and/or orientation of the magnetic fieldgenerating device the at least muscle contraction may occur in bicepsbrachii muscle, brachialis muscle, coracobrachialis muscle and/ortriceps brachii muscle.

The treatment may cause circumferential reduction of the arm. Furtherthe muscle may obtain enhanced visual appearance, arm may bewell-shaped. Arm contour may be enhanced as well.

The at least muscle contraction may be more efficient for adipose tissuemetabolism as the value of magnetic flux density increases since themuscle contraction may be stronger. The higher magnetic flux density maytreat the higher number of muscle fibers contraction and the moreadipose tissue may be reduced. Therefore the visual appearance ofregions prone to cellulite may be enhanced.

Treatment by time-varying magnetic field may induce lipolysis. Adiposetissue may be reduced by decreasing the number and/or volume of adiposecells. Promoted adipose cell metabolism may increase as the value ofmagnetic flux density increases. The treatment may release free fattyacids (FFA) from at least one adipose cell. The increased concentrationof FFA may influence a homeostasis of the adipose cell. A disruption ofthe homeostasis may cause a dysfunction of the adipose cell. Thedysfunction may be followed by stress for endoplasmic reticulum (ERstress). ER stress may cause additional lipolysis and/or apoptosis ofthe at least one adipose cell.

Furthermore, ER stress may cause increase of intracellular calcium ions(Ca2+) which may promote an apoptotic process and may continue intocontrolled cell death of the adipose cell. The apoptosis may be inducedby Ca-dependent effectors, e.g. calpain or caspase-12. Endogenousligands or pharmacological agents, such as vitamin D, may induceprolonged cytosolic calcium increase. Vitamin D may influence release ofCa2+ from endoplasmic reticulum. Hence the effect of treatment may beenhanced by application of vitamin D and/or Ca2+ prior, during and/orafter the treatment. The most significant effect may be achieved byapplication of both, Ca2+ and vitamin D, prior the treatment to provideall factors influencing adipose cell apoptosis.

Alternatively, increased level of Ca2+ may induce autophagy withinadipose cell as well. Autophagy is self-eating process of cellularorganelles to produce energy and it may proceed into cell death.Autophagy may be induced by ER stress or it may be induced via Ca2+signaling.

FIG. 9 illustrates pathways which may induce apoptosis of the at leastone adipose cell. FFA may accumulate in the at least one adipose cell(32). The magnetic field may induce lipolysis (33), i.e. a release ofFFA from adipose tissue. Accumulated FFA may reach a threshold whenadipose cell is unable to utilize FFA. A dysfunction of the adipose cellmay occur. The adipose cell may react on the dysfunction by ER stress(34). ER stress may induce lipolysis hence additional release of FFA mayoccur (32). ER stress may cause apoptosis of the adipose cell (35).Furthermore, the ER stress may release Ca2+ (36) which may contributethe apoptosis (35).

The effect of the treatment by magnetic field for adipose tissuereduction may be influenced by various biological processes and/orpathways as recited above. The processes and/or pathways may be synergichence the adipose tissue reduction may be accelerated and/or moreefficient.

The method may cause the circumferential reduction i.e. a reduction ofthe size of the treated body region. The method may be mostly indicatedfor the regions with cellulite, particularly for thighs, buttocks,saddlebags, love handles, abdomen, hips and/or arms. However, theindication is not limited to the mentioned regions and the method may beused for treatment of any other body region.

Furthermore, the method may change BMI index of the patient. In apreferred application the BMI of the patient may be reduced.Alternatively, the BMI of the patient may increase.

According to one application the time-varying magnetic field may beapplied in various pulse sequences called protocol. Each protocol mayinclude a plurality of sections including trains and bursts which variesfor improving the treatment result. The treatment results may differfollowing the protocol. The train includes a plurality of subsequentmagnetic pulses, i.e. at least two pulses. Burst includes the train anda time with no magnetic field generated. The train may last at least 4,8, 25, 100, 200, 250, 300, 500 ms or 1, 2, 4, 5, 7.5, 10 12.5, 15 ormore seconds. The train may be in order of tens of seconds as well. Anexemplary treatment may include at least 2, 5, 10, 25, 50, 100, 250 or500 bursts. Alternatively the treatment may include a number of burstsin a range of 15 to 25000, preferably in a range of 40 to 10000, morepreferably in a range of 75 to 2500, even more preferably in a range of150 to 1500, most preferably in a range of 300 to 750 or up 100000. Atime between two subsequent trains may be at least 5, 10, 50, 100, 200,500, 750 ms. Alternatively the time between two subsequent trains maylast in order of ones or tens of seconds such as 1, 2, 2.5, 5, 7.5, 10,15, 20 seconds or more.

The protocol may include a plurality of sections. The sections may begenerated sequentially. The sections may include different treatmentparameters such as a repetition rate; a number of impulses in a train; aburst duration or a modulation of the time-varying magnetic field, i.e.changing the treatment parameters in time. An amplitude modulation ofthe time-varying magnetic field may be used, i.e. a modulation inmagnetic flux density. The modulation in magnetic flux density may beinterpreted as changing the amplitude of the magnetic pulses in order togenerate an envelope.

The train is a group of subsequent impulses delivered to the patient.The burst includes one train and time of no magnetic field generation.The section may include a plurality of trains and/or bursts. Theimpulses in one train may preferably differ in magnetic flux density inorder to establish a train shape. The train shape is herein after as anenvelope. The section includes may include a plurality of identicaltrains, envelope included.

The section may include specific train duration, the burst duration orthe section duration. The magnetic flux density may be modulated inamplitude to enable treatment of various envelopes. Different envelopesare differently perceived by the patient.

Trapeziodal envelope is perceived by the patient as the mostcomfortable. Trapeziodal envelope respects natural course of musclecontraction, i.e. the muscle contraction may be time-varying. Strengthof natural muscle contraction increases, holds at the highest strengthand decreases. Similarly the trapeziodal envelope corresponds withnatural muscle contraction, i.e. the strength of the muscle contractionmay correspond with the magnetic flux density. The magnetic flux densityincreases, holds and decreases.

FIG. 13 illustrates an exemplary trapezoidal envelope. Vertical axis mayrepresent magnetic flux density. Horizontal axis may represent time.T_(R) is time with increasing magnetic flux density called increasingtransient time, i.e. the amplitude of the magnetic flux density mayincrease. T_(H) is time with maximal magnetic flux density, i.e. theamplitude of the magnetic flux density may be constant. T_(F) is timewith decreasing magnetic flux density, i.e. the amplitude of themagnetic flux density may decrease. A sum of T_(R),T_(H) and T_(F) maybe trapezoidal envelope duration.

The trapezoidal envelope may decrease energy consumption. The biologicaleffect caused by trapezoidal envelope may equal to biological effectcaused by a rectangular envelope. Due to lower energy consumption thetrapezoidal shape may enable improved cooling of the magnetic fieldgenerating device. Further the resistive losses may be reduced due tolower temperature of the magnetic field generating device.

Different repetition rate may cause different type of musclecontraction. Each type of muscle contraction may consume differentenergy.

FIG. 14 illustrates different types of muscle contraction. The musclecontraction may differ in energy consumption. Vertical axis mayrepresent a strength of the muscle contraction. Horizontal axis mayrepresent time. Arrows may represent magnetic pulses applied to themuscle of the patient.

Low repetition rate of the time-varying magnetic field pulses, e.g. 1,2, 5 or up to 15 Hz, may cause a twitch. Low repetition rate may besufficiently low to enable the treated muscle to fully relax. The energyconsumption of the treated muscle may be low due to low repetition rate.

Intermediate repetition rate of the time-varying magnetic field pulses,e.g. 15, 20, 25 or up to 29 Hz, may cause incomplete tetanus musclecontraction. Incomplete tetanus may be defined by a repetition rate in arange of 10 to 30 Hz. The muscle may not fully relax. The muscle may bepartially relaxed. The muscle contraction strength may increase withconstant magnetic flux density applied.

Higher repetition rate of the time-varying magnetic field pulses, e.g.30, 35, 40 Hz or higher up to 90 Hz, may cause complete tetanus musclecontraction. The complete tetanus muscle contraction may cause thestrongest supramaximal muscle contraction. The supramaximal musclecontraction may be stronger than volitional muscle contraction. Theenergy consumption may be higher. The strengthening effect may beimproved. Further, it is believed that at repetition rates of at least30 Hz the adipose cells may be reduced in volume and/or in number.

Even higher repetition rate of the time-varying magnetic field pulsesover 90 Hz may suppress and/or block pain excitement transmission atdifferent levels or neural system and/or pain receptors. The repetitionrate may be preferably at least 100 Hz, more preferably at least 120 Hz,most preferably at least 140 Hz. The application of time-varyingmagnetic field to the muscle of the patient may cause pain reliefeffect.

High repetition rate of the time-varying magnetic field pulses over 120Hz may relieve a tonus of the muscle. The repetition rate may bepreferably at least 150 Hz, more preferably at least 180 Hz, mostpreferably at least 200 Hz. The application of the time-varying magneticfield to the muscle of the patient may cause myorelaxation effect.

A quality of the muscle contraction caused by the time-varying magneticfield may be characterized by parameters such as a contractile force ofthe muscle contraction, a muscle-tendon length, a relative shortening ofthe muscle or a shortening velocity of the muscle.

The contractile force of the muscle contraction may reach a contractileforce of at least 0.1 N/cm² or up to 250 N/cm². The contractile forcemay be in a range of 0.5 to 200 N/cm², more preferably in the range of 1to 150 N/cm², most preferably in the range of 2 to 100 N/cm².

The muscle-tendon length may reach up to 65% of a rest muscle-tendonlength. The muscle-tendon length may be preferably in a range of 1 to60% of the rest muscle-tendon length, more preferably in a range of 3 to55% of the rest muscle-tendon length, most preferably in a range of 5 to50% of the rest muscle-tendon length.

The muscle may be shortened during the muscle contraction up to 60% of arest muscle length. The muscle shortening may be in a range of 0.1 to50% of the rest muscle length, more preferably in the range of 0.5 to40% of the rest muscle length, most preferably in the range of 1 to 25%of the resting muscle length.

The muscle may shorten at a velocity of up to 10 cm/s. The muscleshortening velocity may be preferably in a range of 0.1 to 7.5 cm/s,more preferably in the range of 0.2 to 5 cm/s, most preferably in therange of 0.5 to 3 cm/s.

According to one application, a time-varying magnetic field may beapplied to the patient in order to cause a muscle shaping effect bymuscle contraction. The muscle may obtain increased tonus and/or volume.Strength of the muscle may increase as well.

The application may be intended for muscle treatment. The treatment byrepetition rate up to 45 Hz may provide significant treatment results inmuscle shredding effect. The muscle shaping protocol may include threesections of different repetition rates and time durations.

First section may include a repetition rate in a range of 10 to 30 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time in a range of 0.75 to 2.5 seconds. Then themagnetic flux density may decrease to zero for a time in a range of 0.5to 1.5 seconds. Afterward the relaxation period may follow for a time ina range of 1 to 5 seconds, i.e. no time-varying magnetic field may beapplied to the patient. The total time duration of the burst may be in arange of 2.5 to 10 seconds. The section duration may be 30 to 150seconds.

First section may be used for preparing the muscle for the followingsection. The section may heat up the muscle. Further the bloodcirculation may be improved to provide enough energy and/or oxygen tothe treated muscle.

Second section may include a repetition rate in a range of 20 to 40 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time in a range of 1 to 3 seconds. Then themagnetic flux density may decrease to zero for a time in a range of 0.5to 1.5 seconds. Afterward the relaxation period may follow for a time ina range of 1 to 7 seconds, i.e. no magnetic field may be applied to thepatient. The total time duration of the burst may be in a range of 2.75to 12.5 seconds. The section duration may be in a range of 50 to 250seconds.

The second section includes higher repetition rate than the firstsection. The higher repetition rate may enable stronger musclecontraction of the treated muscle. The supramaximal muscle contractionmay cause improved muscle shaping effect. Further the time duration ofmaximal magnetic flux density application is longer with respect to thefirst section. The longer and/or the stronger the muscle contraction theimproved muscle shaping effect may be caused. On the other hand thelonger and/or the stronger the muscle contraction the more lactate maybe formed. The longer relaxation period may be required during thesecond section compared to first section, i.e. the time-varying magneticfield is not applied to the patient.

Third section may include a repetition rate in a range of 2 to 6 Hz. Themaximal magnetic flux density may be maintained at maximal acceptablevalue which may be perceived by the patient. Trains may be modulated inmagnetic flux density to a trapezoidal envelope. The trapezoidalenvelope may include increasing transient time duration in a range of0.5 to 1.5 seconds. After the magnetic flux density reaches the maximalvalue the magnetic flux density may be maintained at the maximalacceptable value for a time on a range of 0.5 to 1.5 seconds. Then themagnetic flux density may decrease to zero for a time in range 2.5 to7.5 seconds. Afterward the period of no applying the magnetic field tothe patient may follow for a time in a range of 3 to 12 seconds. Thetotal time duration may be in a range 6 to 22 seconds. The sectionduration may be in a range of 30 to 110 seconds.

The third section may be used for muscle relaxation. Relaxation sectionis important to enable long lasting treatment without exhausting thetreated muscle. The relaxation section may prevent a lactateaccumulation and muscle pain after the treatment. The relaxation sectionmay cause massage effect. The relaxing section may include the lowerrepetition rate and the longest relaxation period. Further therelaxation section may extend the treatment time and increase thetreatment results.

The treatment may include a plurality of sections. The sections may berepeatedly applied to the patient for a time in a range of 10 to 240minutes, more preferably in a range of 15 to 120 minutes, mostpreferably in a range of 30 to 60 minutes at maximal magnetic fluxdensity at maximal acceptable value by the patient. According toexemplary application the sections may be applied to the patient in arange of three to ten times within one treatment.

According to another application the time-varying magnetic field may beapplied to the patient in order to cause muscle shaping effect by musclecontraction and a reduction of adipose cells. The muscle may obtainincreased tonus and/or volume. Strength of the muscle may increase aswell. The adipose cells may be reduced in number and/or volume.

The application may be intended for adipose cells reduction and for themuscle treatment. The combined protocol may include three sections ofdifferent repetition rates and time durations.

The application may begin with a repetition rate suitable for causingstrong muscle contractions in order to heat up the treated muscles invery short time duration in order to burn glycogen.

First section may include a repetition rate in a range of 20 to 40 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for 0.5 to 2 seconds. Then the magnetic flux densitymay decrease to zero for a time in a range of 0.75 to 4 seconds.Afterward the relaxation period may follow for a time in a range of 1 to5 seconds, i.e. no time-varying magnetic field may be applied to thepatient. The total time duration of the burst may be in a range of 2.5to 12 seconds. The section duration may be in a range of 40 to 200seconds.

First section may be used for strong muscle contraction of the treatedmuscle. The supramaximal muscle contraction may cause improved muscleshaping effect. Further short time duration of maximal magnetic fluxdensity application may provide improved blood perfusion of the muscle.The section duration may be sufficiently long to shred the treatedmuscle.

Second section may include a repetition rate of 30 to 60 Hz. The maximalmagnetic flux density may be maintained at maximal acceptable valuewhich may be perceived by the patient. Trains may be modulated inmagnetic flux density to a trapezoidal envelope. The trapezoidalenvelope may include increasing transient time duration in a range 0.25to 1000 ms. After the magnetic flux density reaches the maximal valuethe magnetic flux density may be maintained at the maximal acceptablevalue for a time in a range of 2 to 5 seconds. Then the magnetic fluxdensity may decrease to zero for a time in a range of 0.5 to 2 seconds.Afterward the relaxation period may follow for a time in a range of 2 to10 seconds, i.e. no magnetic field may be applied to the patient. Thetotal time duration of the burst may be in a range of 5 to 15 seconds.The section duration may be in a range of 35 to 150 seconds.

The second section includes higher repetition rate than the firstsection. It is believed that the repetition rate up to 30 Hz may resultin muscle forming. The repetition rate over 30 Hz may result in adiposecells reduction due to increased energy consumption of the treatedmuscle to sustain the supramaximal muscle contraction. The increasedenergy consumption may result in a metabolism of adipose cells. Theadipose cells may be reduced by number and/or volume. Time duration ofmaximal magnetic flux density application is longer with respect to thefirst section. The longer and/or the stronger the muscle contraction themore adipose cells may be reduced. On the other hand the longer and/orthe stronger the muscle contraction the more lactate may be formed. Thelonger relaxation period may be required during the second sectioncompared to first section, i.e. the time-varying magnetic field is notapplied to the patient.

Third section may include a repetition rate in a range of 2 to 8 Hz. Themaximal magnetic flux density may be maintained at maximal acceptablevalue which may be perceived by the patient. Trains may be modulated inmagnetic flux density to a trapezoidal envelope. The trapezoidalenvelope may include increasing transient time duration of a time in arange of 0.25 to 1.5 seconds. After the magnetic flux density reachesthe maximal value the magnetic flux density may be maintained at themaximal acceptable value for a time in a range of 0.25 to 2.5 seconds.Then the magnetic flux density may decrease to zero for a time in arange of 2 to 8 seconds. Afterward the period of no applying themagnetic field to the patient may follow for a time in a range of 3 to10 seconds. The total time duration of the burst may be in a range of 5to 20 seconds. The section duration may be in a range of 50 to 250seconds.

The third section may be used for muscle relaxation. Relaxation sectionmay enable long lasting treatment without exhausting the treated muscle.The relaxation section may prevent a lactate accumulation and musclepain after the treatment. Further the relaxation section includesapplying the time-varying magnetic field to the muscle of the patientwith repetition rate in a range of 2 to 8 Hz. The relaxation may beactive relaxation. The muscle may be relaxed and the metabolism may notbe immediately stopped. The relaxation section may cause massage effect.The relaxing section may include the lower repetition rate and thelongest relaxation period. Further the relaxation section may extend thetreatment time and increase the treatment results.

The treatment may include a plurality of sections. The sections may berepeatedly applied to the patient for a time in a range of 10 to 240minutes, more preferably in a range of 15 to 120 minutes, mostpreferably in a range of 30 to 60 minutes at maximal magnetic fluxdensity at maximal acceptable value by the patient. According toexemplary application the sections may be applied to the patient sixtimes within one treatment.

The maximal magnetic flux density of the train may be maintained atmaximal acceptable value during the treatment for at least 10 minutes,more preferably around 30 minutes. On the other hand the maximalmagnetic flux density of the train may be maintained below maximalacceptable value during the treatment longer than 30 minutes, morepreferably up to 240 minutes. It may be recommended to maintain themaximal magnetic flux density of the train in a range of 80 to 95% ofthe maximal acceptable value by the patient in order to preventexhaustion of the treated muscle. The longer the treatment the improvedtreatment effect may be caused.

The glycogen storage may decrease in short time duration due tosupramaximal muscle contractions. The first section may be used forcausing the muscle shredding effect and also for promoting energyconsumption in order to start the adipose cell metabolism. The secondsection is believed to activate adipose cells metabolism in order toreduce the adipose cells in number and/or volume. The first and thesecond sections may demand high energy consumption of the treatedmuscle.

The time-varying magnetic field may be applied to the patient by oneapplicator. A plurality of applicators may also be used. In an exemplaryembodiment two applicators may be used for treating large body regionssuch as abdomen. Alternatively two applicators may be used for treatinglateral muscles such as muscles of buttocks or thighs.

The magnetic field may be applied to the patient's in a sequence formuscle shaping. The muscle shaping effect may be preferably used fortightening thighs of the patient, increasing volume of a buttock,lifting the buttock and/or shredding abdominal muscles of the patient.The applicator including the magnetic field generating device maycontact the patient in a body region on transversal circumference of thepatient's body between rib-cage and popliteal fossa. Alternatively theapplicator may be placed above another muscle to be shredded, tonedand/or volumized.

Shaping a buttock may be caused by application the time-varying magneticfield to the muscles of buttock or surrounding muscles, e.g. tensorfasciae latae muscle or at least one of gluteal muscles: maximus, mediusor minimus. In one preferred application all three gluteal muscles maybe treated. By the complex treatment and supramaximal muscle contractionof buttock the muscles are strengthened, toned, the cellulite may bereduced and dimples may be removed. Buttocks and even the patient'sfigure may be enhanced in visual shape appearance and become moreattractive. Buttocks become well-shaped, round, firm, well-trained,toned, smoother, tight and lifted. The complex treatment may reducehips, make perfect round and lifted buttocks, increasing theself-confidence of the patient. Without being limited, it is believedthat the exercising of the gluteus medius may reduce the volume of thebuttocks; exercising of the gluteus maximus may shape and/or lift thebuttocks; exercising of the gluteus minimus may lift the buttocks.Furthermore, the gluteal muscles may grow as well.

The gluteal muscles are inervated by n. gluteus inferior and n. gluteussuperior. Further m. piriformis is innervated by n. plexus sacralis. Themagnetic field generating device may by placed within proximity of thepatient over medial part of m. piriformis. All muscles of patient'sbuttocks may be treated in such a position of the magnetic fieldgenerating device.

In an exemplary application the magnetic field may be applied to thebuttocks. The applicators may be placed in four regions of the buttocks.The buttock may be divided into four regions. FIG. 15 illustratesexemplary regions for placing the applicator. The magnetic fieldgenerating devices are represented by dotted ovals on the patient'sbody. Each region may treat specific muscles in order to enable tailormade application following the patient's need. The applicator may beplaced to the region. In a preferred application the applicatorincluding the magnetic field generating device may be placed on thepatient between gluteal fold and iliac crest. The applicator may beattached to the patient by a length adjustable positioning member suchas belt. The buttock may become firm, toned and/or round shaped.

Further abdominal muscles may be treated, e.g. rectus abdominis muscle,external oblique muscle, internal oblique muscle or transversusabdominis muscle. Rectus abdominis muscle is innervated by nn.intercostale and n. subcostalis. Exemplary placing of the magnetic fieldgenerating device may be over abdominal area down from the costaetowards the pelvis. External and internal oblique muscle and transversusabdominis muscle are innervated by nn. intercostales, n. subcostalis, n.iliohypogastricus, n. ilioinguinalis, n.genitofemoralis.

At least one applicator including at least one magnetic field may beplaced in contact with the patient between rib-cage and pelvis of thepatient. Alternatively the applicator may be placed in a body regionbetween sternum and anterior superior iliac spine. The applicator may belaterally shifted. Exemplary placement of the magnetic field generatingdevice may be between costae and crista iliaca superior and/or pubicbone. An optimal placement of the magnetic field generating device maybe determined by moving the magnetic field generating device towards m.rectus abdomis in order to cause the strongest muscle contraction. Themuscles of abdomen become toned, shredded and/or well-shaped. Thestrength of the treated muscles increases as well. The volume of thegluteal muscle may increase as well. FIG. 16 illustrates exemplaryplacing of the applicators.

In an exemplary application the magnetic field may be applied to theabdomen of the patient. The applicator may be placed preferably caudallyfrom the lowest ribs of the patient in a distance up to 10 cm from thecenter of the magnetic field generating device. The location down of theribs may be well accepted by the patient. The applicator may not touchthe ribs of the patient. Discomfort caused by the pressure applied tothe ribs by the applicator may be reduced. Alternatively the magneticfield generating devices may be shifted in lateral direction.

In a preferred application two applicators may be placed on the patientand fixed by a positioning member, e.g. belt. The two applicators may beplaced laterally on the patient. In an alternative application aplurality of the magnetic field generating devices may be within oneapplicator covering the abdominal area. The magnetic field generatingdevices may be moveable within the applicator.

The application of the time-varying magnetic field to the abdominalregion may increase an apoptotic index for at least 5% with respect toan apoptotic index prior to treatment. The apoptotic index may beincreased by the treatment of the abdominal region in a range of 50 to400%, preferably in a range of 60 to 250%, more preferably in a range of75 to 175%, most preferably in a range of 90 to 150%, or up to 600%.Further repeating the treatment method may decrease a fat layerthickness for at least 0.1%, preferably in a range of 0.5 to 60%, morepreferably in a range of 1 to 50%, even more preferably in a range of 2to 40%, most preferably in a range of 3 to 30% or up to 75% in theabdominal region. Further the abdominal muscles may increase across-section thickness for at least 0.1%, preferably in a range of 0.5to 50%, more preferably 1 to 35%, even more preferably in a range of 2to 30%, most preferably in a range of 3 to 25% or up to 75%.Furthermore, diastasis of abdominal muscles such as rectus abdominis maybe reduced up to 50%, preferably in a range of 1 to 30%, more preferably2 to 35%, most preferably in a range of 3 to 30%. Moreover therepetitive treatment may cause a circumferential reduction of abdominalregion and/or waist. The circumferential reduction may be at least 0.5cm, preferably at least 1 cm, more preferably at least 2 cm, even morepreferably at least 3 cm, most preferably at least 5 cm or up to 25 cm.Alternatively the circumferential reduction may be at least 1%,preferably at least 2%, more preferably at least 4%, even morepreferably at least 8%, most preferably around 10% or up to 15% of thecircumferential length prior the first treatment.

Further the muscles of thigh may be treated, e.g. tensor fascia lataemuscle, vastus lateralis muscle or iliotibial muscle. The thighs mayobtain lifted appearance and/or the contour may be improved. Thesaddlebacks may be reduced as well.

One exemplary application of the time-varying magnetic field for causingthe muscle contraction may be placing the magnetic field generatingdevice over m. quadriceps femoris innervated by n. femoralis. Themagnetic field generating device may be placed within proximal end ofthe m. quadriceps femoris. The magnetic field generating device may beplaced in distal direction to popliteal fossa.

Alternative exemplary application of thigh treatment may be applicationof time-varying magnetic field to m. biceps femoris, m. semimembranosusand/or semitendinosus (so called hamstrings) innervated by n.ischiadicus and n. tibialis. The magnetic field generating device may beplaced within close proximity of gluteal sulcus, the so called glutealfold. The magnetic field generating device may be placed in distaldirection.

In an alternative application, muscles of calf may be treated by thetime-varying magnetic field, .e.g m. triceps surae innervated by n.tibialis. One exemplary placement of the magnetic field generatingdevice may be close to popliteal fossa. Alternatively the magnetic fieldgenerating device may be placed in distal direction.

In an alternative application, an arm of the patient may be treated bythe time-varying magnetic field. Flexors of the arm, e.g. m. bicepsbrachialis or m. coracobrachialis innervated by n. musculocutaneus, maybe treated by the magnetic field generated by the magnetic fieldgenerated device placed on anterior side of the arm in a proximaldirection from m. deltoideus. Extensors of the arm, e.g. m. tricepsbrachii or m. anconeus innervated by n. radialis, may be treated by amagnetic field generating device placed on the posterior side of the armin a proximal direction from m. deltoideus. The magnetic fieldgenerating device may be placed at a distal end of the muscle .

In an alternative application, muscles of a forearm of the patient maybe treated by the time-varying magnetic field. The muscles of theforearm are innervated by n. radialis, n. medialis and/or n. ulnaris.The magnetic field generating device may be placed proximally from theelbow. The magnetic field generating device may be placed at a distalend of the muscles.

In an alternative application, pectoral muscles innervated by nn.Pectorals laterales or mediales may be treated. An exemplary applicationmay be placing the magnetic field generating device to subclaviculararea in order to treat mm. pectorales minors. Alternatively placing themagnetic field generating device to parasternal area may treat mm.pectorales majors. The magnetic field generating device may be placedproximal to the sternum of the patient.

Alternatively, neck muscles may also treated by applying thetime-varying magnetic field to the suprascapular region. The applicatormay be also placed in a cranial direction above clavicle. The treatmentmay cause submental tightening and/or platysma tightening. Neckrejuvenation may be caused as well.

Alternatively, head muscles such as facial muscles may be treated bytime-varying magnetic field. One exemplary application may be treatmentof m. buccalis, orbicularis oris or oculi etc. The treatment may causefacial rejuvenation.

The treatment is more efficient than standard workout in fitness sincethe machines strengthen only the isolated muscles and/or muscles groups.The results may be achieved in very short-time periods with minimal timeof treatment.

In the preferred application the magnet treatment may be combined withother treatment methods using different approaches, e.g. conventionalnon-invasive treatments. The combined treatment may be applied to thesurroundings tissues around buttocks to reduce the cellulite around thebuttocks and enhance the shape of the enhanced appearance of thebuttocks. The surrounding tissues may be represented by e.g. abdomen,love handles, thighs or saddle bags.

According to another application the time-varying magnetic field may beapplied to the patient in order to cause muscle shaping effect by musclecontraction and a reduction of adipose cells. The muscle may obtainincreased tonus and/or volume. Strength of the muscle may increase aswell.

The treatment may be used for improvement of a region of pelvic floorand/or surrounding tissues such as female genital tissue including vulvaand vagina. The muscle in proximity of vagina may be toned or tightened.The vagina may be tightened as well. Further the sexual arousal may beimproved due to the tightened muscles. Similar effect may be caused inmale population. The muscles of pelvic floor may be strengthened anderectile function may be improved.

The combined protocol may include three sections of different repetitionrates and time durations.

First section may include a repetition rate in a range of 90 to 150 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 1 to 5 seconds. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time in a range of 1 to 5 seconds. Then themagnetic flux density may decrease to zero for a time in a range of 1 to5 seconds. Afterward the relaxation period may follow for a time in arange of 1 to 5 seconds, i.e. no time-varying magnetic field may beapplied to the patient. The total time duration of the burst may be in arange of 4 to 20 seconds. The section duration may be in a range of 10to 50 seconds.

First section may be used for preparing the muscle for the followingsection. The section may heat up the muscles. Further the bloodcirculation may be improved to provide enough energy and/or oxygen tothe treated muscle. The repetition rate in the range of 90 to 150 Hzmodulated in magnetic flux density may be well-accepted by the patient.It may be comfortable for the patient due to pain relieving effect ofrepetition rates over 80 Hz. Further the muscle may be contracted ascomplete tetanic muscle contraction.

Second section may include repetition rates in a range of 10 to 45 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 1 to 5 seconds. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time in a range of 1 to 5 seconds. Then themagnetic flux density may decrease to zero for a time in a range of 1 to5 seconds. Afterward the relaxation period may follow for a time in arange of 1 to 5 seconds, i.e. no magnetic field may be applied to thepatient. The total time duration of the burst may be in a range of 4 to20 seconds. The section duration may be in a range of 60 to 300 seconds.The repetition rates may vary after one cycle of the section, e.g. firstcycle may include the repetition rate in a range of 15 to 25 Hz, secondcycle may include the repetition rate in a range of 20 to 30 Hz andthird cycle may include the repetition rate in a range of 25 to 40 Hz.

The second section includes lower repetition rate than the firstsection. The lower repetition rate may enable stronger musclecontraction of the treated muscle. The supramaximal muscle contractionmay cause improved muscle shaping effect. Further the time duration ofthe second section is longer with respect to the first section. Furtherthe different repetition rates may cause different muscle contraction.Thy muscle contraction may vary from incomplete to complete tetanusmuscle contraction. The longer relaxation period may be required duringthe second section compared to first section, i.e. the time-varyingmagnetic field is not applied to the patient.

Third section may include a repetition rate up to 2 Hz. The maximalmagnetic flux density may be maintained at maximal acceptable valuewhich may be perceived by the patient. Trains may be modulated inmagnetic flux density to a trapezoidal envelope. The trapezoidalenvelope may include increasing transient time duration in a range of 1to 5 seconds. After the magnetic flux density reaches the maximal valuethe magnetic flux density may be maintained at the maximal acceptablevalue for a time in a range of 1 to 5 seconds. Then the magnetic fluxdensity may decrease to zero for a time in a range of 1 to 5 seconds.Afterward the period of no applying the magnetic field to the patientmay follow for a time in a range of 1 to 5 seconds. The total timeduration of the burst may be in a range of 4 to 20 seconds. The sectionduration may be in a range of 15 to 200 seconds.

The third section may be used for muscle relaxation. Relaxation sectionis important to enable long lasting treatment without exhausting thetreated muscle. The relaxation section may prevent a lactateaccumulation and muscle pain after the treatment. The relaxation sectionmay cause massage effect. The relaxing section may include the lowerrepetition rate and the longest relaxation period. The repetition rateup to 2 Hz causes effect similar to manual massage. The twitch mayprovide high quality relaxation to the treated muscle. Further therelaxation section may extend the treatment time and increase thetreatment results.

The treatment may include a plurality of sections. The sections may berepeatedly applied to the patient for a time in a range of 10 to 240minutes, more preferably in a range of 15 to 120 minutes, mostpreferably in a range of 30 to 60 minutes at maximal magnetic fluxdensity at maximal acceptable value by the patient. According toexemplary application the sections may be applied to the patient threeto ten times within one treatment.

First section may include a repetition rate in a range of 80 to 180 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for 0.5 to 2 seconds. Then the magnetic flux densitymay decrease to zero for a time in a range of 0.75 to 4 seconds.Alternatively the envelope may be rectangular for a time period in arange of 1.5 to 7 seconds, i.e. with no modulation. Afterward therelaxation period may follow for a time in a range of 1 to 5 seconds,i.e. no time-varying magnetic field may be applied to the patient. Thetotal time duration of the burst may be in a range of 2.5 to 12 seconds.The section duration may be in a range of 40 to 200 seconds.

First section may be used for temporary pain relief effect. Thetemporary pain relief effect may enable applying higher magnetic fluxdensity during the following sections. The rectangular envelopes maycause effect similar to muscle blood pump.

Second section may include a repetition rate of 30 to 60 Hz. The maximalmagnetic flux density may be maintained at maximal acceptable valuewhich may be perceived by the patient. Trains may be modulated inmagnetic flux density to a trapezoidal envelope. The trapezoidalenvelope may include increasing transient time duration in a range 0.25to 1000 ms. After the magnetic flux density reaches the maximal valuethe magnetic flux density may be maintained at the maximal acceptablevalue for a time in a range of 2 to 5 seconds. Then the magnetic fluxdensity may decrease to zero for a time in a range of 0.5 to 2 seconds.Afterward the relaxation period may follow for a time in a range of 2 to10 seconds, i.e. no magnetic field may be applied to the patient. Thetotal time duration of the burst may be in a range of 5 to 15 seconds.The section duration may be in a range of 35 to 150 seconds.

The second section includes lower repetition rate than the firstsection. It is believed that the repetition rate up to 30 Hz may resultin muscle forming. The repetition rate over 30 Hz may result in adiposecells reduction due to increased energy consumption of the treatedmuscle to sustain the supramaximal muscle contraction. The increasedenergy consumption may result in a metabolism of adipose cells. Theadipose cells may be reduced by number and/or volume. Time duration ofmaximal magnetic flux density application is longer with respect to thefirst section. The longer and/or the stronger the muscle contraction themore adipose cells may be reduced. On the other hand the longer and/orthe stronger the muscle contraction the more lactate may be formed. Thelonger relaxation period may be required during the second sectioncompared to first section, i.e. the time-varying magnetic field is notapplied to the patient.

Third section may include a repetition rate in a range of 150 to 250 Hz.The maximal magnetic flux density may be maintained at 25, 50 or 75% ofthe maximal acceptable value which may be perceived by the patient.Trains may be not be modulated. The rectangular envelope may be appliedto the patient for a time period in a range of 5 to 10 seconds.Afterward the period of no applying the magnetic field to the patientmay follow for a time in a range of 3 to 10 seconds. The total timeduration of the burst may be in a range of 8 to 20 seconds. The sectionduration may be in a range of 50 to 250 seconds.

The third section may be used for muscle relaxation. Relaxation sectionmay enable long lasting treatment without exhausting the treated muscle.The high repetition rate may cause high quality muscle relaxation effectfor the treated muscle. Further the relaxation section may extend thetreatment time and increase the treatment results.

A group of the second and the third section may be repeated for threetimes to 15 times.

Fourth section may include a repetition rate in a range of 2 to 10 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 0.5 to 1.5 seconds. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time on a range of 0.5 to 1.5 seconds. Then themagnetic flux density may decrease to zero for a time in range 2.5 to7.5 seconds. Afterward the period of no applying the magnetic field tothe patient may follow for a time in a range of 3 to 12 seconds.Alternatively the magnetic field may be applied to the muscle as a trainof pulses of repetition rate in a range 1 to 5 Hz for a period in arange of 10 to 30 seconds. The total time duration may be in a range 6to 30 seconds. The section duration may be in a range of 30 to 110seconds.

The fourth section may be used for muscle relaxation. Relaxation sectionis important to enable long lasting treatment without exhausting thetreated muscle. The relaxation section may prevent a lactateaccumulation and muscle pain after the treatment. The relaxation sectionmay cause massage effect. The relaxing section may include the lowerrepetition rate and the longest relaxation period. Further therelaxation section may extend the treatment time and increase thetreatment results.

The treatment may include a plurality of sections. The sections may berepeatedly applied to the patient for a time in a range of 10 to 240minutes, more preferably in a range of 15 to 120 minutes, mostpreferably in a range of 30 to 60 minutes at maximal magnetic fluxdensity at maximal acceptable value by the patient. According toexemplary application the sections may be applied to the patient in arange of three to ten times within one treatment.

First section may include a repetition rate in a range of 80 to 150 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for 0.5 to 2 seconds. Then the magnetic flux densitymay decrease to zero for a time in a range of 0.75 to 4 seconds.Alternatively the envelope may be rectangular for a time period in arange of 1.5 to 7 seconds, i.e. with no modulation. Afterward therelaxation period may follow for a time in a range of 1 to 5 seconds,i.e. no time-varying magnetic field may be applied to the patient. Thetotal time duration of the burst may be in a range of 2.5 to 12 seconds.The section duration may be in a range of 40 to 200 seconds.

The first section may be used for temporary pain relief effect. Thetemporary pain relief effect may enable applying higher magnetic fluxdensity during the following sections. The rectangular envelopes maycause effect similar to muscle blood pump.

Second section may include a repetition rate in a range of 2 to 10 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 0.5 to 1.5 seconds. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time on a range of 0.5 to 1.5 seconds. Then themagnetic flux density may decrease to zero for a time in range 2.5 to7.5 seconds. Afterward the period of no applying the magnetic field tothe patient may follow for a time in a range of 3 to 12 seconds.Alternatively the magnetic field may be applied to the muscle as a trainof pulses of repetition rate in a range 1 to 5 Hz for a period in arange of 10 to 30 seconds. The total time duration may be in a range 6to 30 seconds. The section duration may be in a range of 30 to 110seconds.

The second section may be used for muscle relaxation. The relaxationsection may cause massage effect. The relaxing section may include thelower repetition rate and the longest relaxation period.

Third section may include a repetition rate of 30 to 60 Hz. The maximalmagnetic flux density may be maintained at maximal acceptable valuewhich may be perceived by the patient. Trains may be modulated inmagnetic flux density to a trapezoidal envelope. The trapezoidalenvelope may include increasing transient time duration in a range 0.25to 1000 ms. After the magnetic flux density reaches the maximal valuethe magnetic flux density may be maintained at the maximal acceptablevalue for a time in a range of 2 to 5 seconds. Then the magnetic fluxdensity may decrease to zero for a time in a range of 0.5 to 2 seconds.Afterward the relaxation period may follow for a time in a range of 2 to10 seconds, i.e. no magnetic field may be applied to the patient. Thetotal time duration of the burst may be in a range of 5 to 15 seconds.The section duration may be in a range of 35 to 150 seconds.

The third section includes higher repetition rate than the secondsection. It is believed that the repetition rate up to 30 Hz may resultin muscle forming. The repetition rate over 30 Hz may result in adiposecells reduction due to increased energy consumption of the treatedmuscle to sustain the supramaximal muscle contraction. The increasedenergy consumption may result in a metabolism of adipose cells. Theadipose cells may be reduced by number and/or volume. Time duration ofmaximal magnetic flux density application is longer with respect to thefirst section. The longer and/or the stronger the muscle contraction themore adipose cells may be reduced. On the other hand the longer and/orthe stronger the muscle contraction the more lactate may be formed. Thelonger relaxation period may be required during the second sectioncompared to first section, i.e. the time-varying magnetic field is notapplied to the patient.

Fourth section may include a repetition rate in a range of 20 to 40 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for 0.5 to 2 seconds. Then the magnetic flux densitymay decrease to zero for a time in a range of 0.75 to 4 seconds.Afterward the relaxation period may follow for a time in a range of 1 to5 seconds, i.e. no time-varying magnetic field may be applied to thepatient. The total time duration of the burst may be in a range of 2.5to 12 seconds. The section duration may be in a range of 40 to 200seconds.

The fourth section may be used for strong muscle contraction of thetreated muscle. The supramaximal muscle contraction may cause improvedmuscle shaping effect. Further short time duration of maximal magneticflux density application may provide improved blood perfusion of themuscle. The section duration may be sufficiently long to shred thetreated muscle.

A group of the third and the fourth section may be repeated for three to15 times.

Fifth section may include a repetition rate in a range of 80 to 150 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for 0.5 to 2 seconds. Then the magnetic flux densitymay decrease to zero for a time in a range of 0.75 to 4 seconds.Alternatively the envelope may be rectangular for a time period in arange of 1.5 to 7 seconds, i.e. with no modulation. Afterward therelaxation period may follow for a time in a range of 1 to 5 seconds,i.e. no time-varying magnetic field may be applied to the patient. Thetotal time duration of the burst may be in a range of 2.5 to 12 seconds.The section duration may be in a range of 40 to 200 seconds.

The fifth section may be used for muscle regeneration after thetreatment. The section may heat up the muscle. Further the bloodcirculation may be improved to provide enough energy and/or oxygen tothe treated muscle.

Sixth section may include a repetition rate in a range of 80 to 150 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 250 to 1000 ms. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for 0.5 to 2 seconds. Then the magnetic flux densitymay decrease to zero for a time in a range of 0.75 to 4 seconds.Alternatively the envelope may be rectangular for a time period in arange of 1.5 to 7 seconds, i.e. with no modulation. Afterward therelaxation period may follow for a time in a range of 1 to 5 seconds,i.e. no time-varying magnetic field may be applied to the patient. Thetotal time duration of the burst may be in a range of 2.5 to 12 seconds.The section duration may be in a range of 40 to 200 seconds.

The sixth section including the repetition rate over 80 Hz may relieve amuscle tonus and/or relax the muscle. Further the section may improvelocal perfusion and/or metabolism. The short rectangular envelopes maycause effect similar to muscle blood pump. The increasing magnetic fluxdensity may increase efficiency of the muscle blood pump.

The treatment may include a plurality of sections. The sections may berepeatedly applied to the patient for a time in a range of 10 to 240minutes, more preferably in a range of 15 to 120 minutes, mostpreferably in a range of 30 to 60 minutes at maximal magnetic fluxdensity at maximal acceptable value by the patient. According toexemplary application the sections may be applied to the patient in arange of three to ten times within one treatment.

According to another application the time-varying magnetic field may beapplied to the patient in order to cause muscle shaping effect by musclecontraction and a reduction of adipose cells. The muscle may obtainincreased tonus and/or volume. Strength of the muscle may increase aswell. The adipose cells may be reduced in number and/or volume.

The protocol may include a plurality of repetition rate of differentbiological effect. The protocol may combine repetition rate in a rangeof 25 to 75 Hz and repetition rates over 80 Hz. The repetition rates inthe range of 25 to 75 Hz may cause a muscle contraction. The musclecontraction may be used for muscle strengthening. On the other hand,repetition rates over 80 Hz, such as 100, 120 and higher may be used forcausing pain relief and/or myorelaxation effect.

The combined protocol may include three sections of different repetitionrates and time durations.

According to another application the protocol may include a pluralitysections.

In general the protocol may include a plurality of section. The protocolmay be used for muscle strengthening, toning.

First section may include a repetition rate in a range of 80 to 150 Hz.The magnetic flux density may be maintained at least at 25%, morepreferably 50%, even more preferably 75% or more of the maximalacceptable value which may be perceived by the patient. Trains may notbe modulated, i.e. the envelope may be rectangular. The train durationmay be in a range of 1 to 1000 ms, more preferably in a range of 5 to500 ms, even more preferably in a range of 10 to 100 ms, most preferablyin a range of 15 to 45 ms. Afterward the relaxation period may followfor a time period in a range of 2 to 2500 ms, more preferably in a rangeof 10 to 1200 ms, even more preferably in a range of 20 to 250 ms, mostpreferably in a range of 35 to 155 ms, i.e. no time-varying magneticfield may be applied to the patient. The total time duration of theburst may be in a range of 3 to 3500 ms, more preferably in a range of15 to 1700 ms, even more preferably in a range of 30 to 350 ms, mostpreferably in a range of 50 to 200 ms. The section duration may be in arange of 3 to 10 seconds or up to 30 seconds. The section may bepreferably repeated at least twice, more preferably 5 times or up to tentimes. The magnetic flux density may preferably increase in thefollowing sections.

The first section including repetition rate over 80 Hz may relieve amuscle tonus and/or relax the muscle. Further the section may improvelocal perfusion and/or metabolism. The short rectangular envelopes maycause effect similar to muscle blood pump. The increasing magnetic fluxdensity may increase efficiency of the muscle blood pump. The firstsection may prepare the treated muscle for treatment by the protocol.

Second section may include a repetition rate in a range of 10 to 30 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 0.5 to 2 seconds. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time a range of 0.5 to 2 seconds. Then themagnetic flux density may decrease to zero for a time a range of 0.5 to2 seconds. Afterward the relaxation period may follow for a time a rangeof 1 to 5 seconds, i.e. no magnetic field may be applied to the patient.The total time duration of the burst may be in a range of 2.5 to 10seconds. The section duration may be in a range of 30 to 120 seconds.The section may be preferably repeated at least twice, more preferablyat least 5 times or up to 10 times. The repetition rate may increasewithin following sections such as 25, 30, 40 or 45 Hz.

The second section includes lower repetition rate than the firstsection. Further the second section may include higher treatment dutycycle than the first section. The lower repetition rate, highertreatment duty cycle and/or the section duration may enable strongermuscle contraction of the treated muscle. The supramaximal musclecontraction may cause improved muscle strengthening and/or toningeffect. Further the time duration of maximal magnetic flux densityapplication is longer with respect to the first section. The longerand/or the stronger the muscle contraction the improved muscle shapingeffect may be caused. On the other hand the longer and/or the strongerthe muscle contraction the more lactate may be formed. The longerrelaxation period may be required during the second section compared tofirst section, i.e. the time-varying magnetic field is not applied tothe patient. The section may maintain the treatment duty cycle at least10%, more preferably at least 25%, most preferably at least 50% in orderto enabled appropriate muscle relaxation.

Third section may include a repetition rate up to 2 Hz. The maximalmagnetic flux density may be maintained at maximal acceptable valuewhich may be perceived by the patient. The time duration of the thirdsection may be in a range of 30 to 120 seconds.

The third section may be used for muscle relaxation. The relaxationsection may prevent a lactate accumulation and muscle pain after thetreatment. The relaxation section may cause massage effect. The relaxingsection may include the lower repetition rate. Further the relaxationsection may extend the treatment time and increase the treatmentresults.

A plurality of second sections and third section may be repeated inorder to establish the complete treatment protocol. The total protocolduration may be 30 minutes.

The treatment may include a plurality of sections. The sections may berepeatedly applied to the patient for a time in a range of 10 to 240minutes, more preferably in a range of 15 to 120 minutes, mostpreferably in a range of 30 to 60 minutes at maximal magnetic fluxdensity at maximal acceptable value by the patient. According toexemplary application the sections may be applied to the patient sixtimes within one treatment.

The protocol may shorten the time duration of the treatment. The numberof the patients treated may increase.

According to another application the time-varying magnetic field may beapplied to the muscle of the patient include preferably a repetitionrate over 80 Hz to provide pain relief effect.

A treatment protocol may include four sections. The section may berepeated within one treatment.

First section may include a repetition rate in a range of 80 to 150 Hz.The magnetic flux density may be maintained at least at 25%, morepreferably 50%, even more preferably 75% or more of the maximalacceptable value which may be perceived by the patient. Trains may notbe modulated, i.e. the envelope may be rectangular. The train durationmay be in a range of 15 to 45 ms. Afterward the relaxation period mayfollow for a time period in a range of 35 to 155 ms, i.e. notime-varying magnetic field may be applied to the patient. The totaltime duration of the burst may be in a range of 50 to 200 ms. Thesection duration may be in a range of 3 to 10 seconds. The section maybe preferably repeated at least twice, more preferably 5 times or up toten times. The magnetic flux density may preferably increase in thefollowing sections.

The first section including repetition rate in a range of 80 to 150 Hzmay relieve a muscle tonus and/or relax the muscle. The repetition ratein the range of 80 to 150 Hz may cause a pain relief effect. Further thesection may improve local perfusion and/or metabolism. The shortrectangular envelopes may cause effect similar to muscle blood pump. Theincreasing magnetic flux density may increase efficiency of the muscleblood pump. The first section may prepare the treated muscle fortreatment by the protocol.

Second section may include a repetition rate in a range of 10 to 30 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 0.5 to 2 seconds. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time in a range of 0.5 to 2 seconds. Then themagnetic flux density may decrease to zero for a time in a range of 0.5to 2 seconds. Afterward the relaxation period may follow for a time in arange of 2 to 10 seconds, i.e. no magnetic field may be applied to thepatient. The total time duration of the burst may be in a range of 3 to15 seconds. The section duration may be in a range of 30 to 150 seconds.

The second section may be repeated with the repetition rate in a rangeof 15 to 45 Hz. The increased repetition rate may increase the effect ofmuscle contraction. The muscle may be strengthened. The local perfusionmay increase as well. The different repetition rate may improve thetreatment results.

The second section includes lower repetition rate than the firstsection. Further the second section may include higher treatment dutycycle than the first section. The lower repetition rate, highertreatment duty cycle and/or the section duration may enable strongermuscle contraction of the treated muscle. The supramaximal musclecontraction may cause improved muscle strengthening and/or toningeffect. The relaxation period in a range of 1 to 5 seconds maysufficiently relax the treated muscle.

Third section may include a repetition rate in a range of 30 to 60 Hz.The maximal magnetic flux density may be maintained in a range of 40 to100%, more preferably in a range of 60 to 90%, most preferably around80% of the maximal acceptable value which may be perceived by thepatient for a time period in a range of 0.1 to 2 seconds. Relaxationperiod in the range of 0.1 to 2 seconds may follow, i.e. no magneticfield may be applied to the patient. The total time duration of theburst may be in a range of 0.2 to 4 seconds. The section duration may bein a range of 0.5 to 30 seconds.

The third section includes higher repetition rate than the firstsection. Further the third section may include higher treatment dutycycle than the second section. The higher repetition rate and/or highertreatment duty cycle may enable stronger muscle contraction of thetreated muscle. The section duration may not exhaust the treated muscle.The supramaximal muscle contraction may cause improved musclestrengthening and/or toning effect. The magnetic flux density decreasingfor a time period in a range of 1.5 to 4.5 seconds may enable to relievethe muscle tonus continually. The relaxation period in a range of 2 to 8seconds may sufficiently relax the treated muscle.

A benefit of such the protocol may be suppressing the pain threshold inorder to enable treat the muscle by higher magnetic flux density. Themuscle may gain higher strength due to applied higher magnetic fluxdensity.

Further benefit of the protocol may be short time duration of theprotocol. The protocol may enable to combine different protocols due totreatment time reduction.

Further the present methods may be used for treatment of disease ofurogenital and/or digestive tract, e.g. improvement of circulationand/or trophic problems, faecal incontinence, urinal incontinence(stress or urge), neuromuscular dysfunction of bladder, mixedincontinence, sexual dysfunction, priapism, erectile dysfunction,orgasmic disorder, fertility issues, chronic pelvic pain syndrome, painin pelvic area, hyperplasia of prostate, prostatitis, prostatodyniasyndrome, dysmenorrhea, vulvodynia, pain and other conditions associatedwith menstrual cycle, menopausal and/or postmenopausal disorders,cystitis (such as interstitial), inflammatory disease of uterus orcervix uteri, parametris, peritonitis, vaginitis, vulvitis,endometriosis, genital prolapse, hemorrhoids, peripheral paresis orpelvic floor issues in general. The present methods may be used formuscle strengthening, muscle relaxation, regeneration after childbirth(such as pelvic floor prolapse), vaginal tightening or scar treating.Alternatively the treatment may improve postoperative tissue healingsuch as scars or wounds.

According to another application the time-varying magnetic field may beapplied to the muscle of the patient include preferably a repetitionrate over 80 Hz to provide pain relief effect.

First section may include a repetition rate in a range of 80 to 150 Hz.The magnetic flux density may be maintained at least at 25%, morepreferably 50%, even more preferably 75% or more of the maximalacceptable value which may be perceived by the patient. Trains may notbe modulated, i.e. the envelope may be rectangular. The train durationmay be in a range of 1 to 1000 ms, more preferably in a range of 5 to500 ms, even more preferably in a range of 10 to 100 ms, most preferablyin a range of 15 to 45 ms. Afterward the relaxation period may followfor a time period in a range of 2 to 2500 ms, more preferably in a rangeof 10 to 1200 ms, even more preferably in a range of 20 to 250 ms, mostpreferably in a range of 35 to 155 ms, i.e. no time-varying magneticfield may be applied to the patient. The total time duration of theburst may be in a range of 3 to 3500 ms, more preferably in a range of15 to 1700 ms, even more preferably in a range of 30 to 350 ms, mostpreferably in a range of 50 to 200 ms. The section duration may be in arange of 3 to 10 seconds or up to 30 seconds. The section may bepreferably repeated at least twice, more preferably 5 times or up to tentimes. The magnetic flux density may preferably increase in thefollowing sections.

The first section including repetition rate over 80 Hz may relieve amuscle tonus and/or relax the muscle. Further the section may improvelocal perfusion and/or metabolism. The short rectangular envelopes maycause effect similar to muscle blood pump. The increasing magnetic fluxdensity may increase efficiency of the muscle blood pump. The firstsection may prepare the treated muscle for treatment by the protocol.

Second section may include a repetition rate in a range of 150 to 250Hz. The maximal magnetic flux density may be maintained at 25, 50 or 75%of the maximal acceptable value which may be perceived by the patient.Trains may be not be modulated. The rectangular envelope may be appliedto the patient for a time period in a range of 5 to 10 seconds.Afterward the period of no applying the magnetic field to the patientmay follow for a time in a range of 3 to 10 seconds. The total timeduration of the burst may be in a range of 8 to 20 seconds. The sectionduration may be in a range of 50 to 250 seconds.

The second section may be used for muscle relaxation. Relaxation sectionmay enable long lasting treatment without exhausting the treated muscle.The high repetition rate may cause high quality muscle relaxation effectfor the treated muscle. Further the relieved tonus may cause pain reliefeffect.

Third section may include a repetition rate in a range of 2 to 10 Hz.The maximal magnetic flux density may be maintained at maximalacceptable value which may be perceived by the patient. Trains may bemodulated in magnetic flux density to a trapezoidal envelope. Thetrapezoidal envelope may include increasing transient time duration in arange of 0.5 to 1.5 seconds. After the magnetic flux density reaches themaximal value the magnetic flux density may be maintained at the maximalacceptable value for a time on a range of 0.5 to 1.5 seconds. Then themagnetic flux density may decrease to zero for a time in range 2.5 to7.5 seconds. Afterward the period of no applying the magnetic field tothe patient may follow for a time in a range of 3 to 12 seconds.Alternatively the magnetic field may be applied to the muscle as a trainof single pulses of repetition rate in a range 1 to 5 Hz for a period ina range of 10 to 30 seconds. The total time duration may be in a range 6to 30 seconds. The section duration may be in a range of 30 to 110seconds.

The third section may be used for muscle relaxation. The relaxationsection may prevent a lactate accumulation and muscle pain after thetreatment. The relaxation section may cause massage effect and/orimprove local blood circulation.

Fourth section may include a repetition rate in a range of 150 to 250Hz. The maximal magnetic flux density may be maintained at 25, 50 or 75%of the maximal acceptable value which may be perceived by the patient.Trains may be not be modulated. The rectangular envelope may be appliedto the patient for a time period in a range of 5 to 10 seconds.Afterward the period of no applying the magnetic field to the patientmay follow for a time in a range of 3 to 10 seconds. The total timeduration of the burst may be in a range of 8 to 20 seconds. The sectionduration may be in a range of 50 to 250 seconds.

The fourth section may be used for muscle relaxation. The highrepetition rate may cause high quality muscle relaxation effect for thetreated muscle. Further the relieved tonus may cause pain relief effect.

Fifth section may include a repetition rate in a range of 80 to 150 Hz.The magnetic flux density may be maintained at least at 25%, morepreferably 50%, even more preferably 75% or more of the maximalacceptable value which may be perceived by the patient. Trains may notbe modulated, i.e. the envelope may be rectangular. The train durationmay be in a range of 1 to 1000 ms, more preferably in a range of 5 to500 ms, even more preferably in a range of 10 to 100 ms, most preferablyin a range of 15 to 45 ms. Afterward the relaxation period may followfor a time period in a range of 2 to 2500 ms, more preferably in a rangeof 10 to 1200 ms, even more preferably in a range of 20 to 250 ms, mostpreferably in a range of 35 to 155 ms, i.e. no time-varying magneticfield may be applied to the patient. The total time duration of theburst may be in a range of 3 to 3500 ms, more preferably in a range of15 to 1700 ms, even more preferably in a range of 30 to 350 ms, mostpreferably in a range of 50 to to 1700 ms, even more preferably in arange of 30 to 350 ms, most preferably in a range of 50 to 200 ms. Thesection duration may be in a range of 3 to 10 seconds or up to 30seconds. The section may be preferably repeated at least twice, morepreferably 5 times or up to ten times. The magnetic flux density maypreferably increase in the following sections.

The fifth section including repetition rate over 80 Hz may relieve amuscle tonus and/or relax the muscle. Further the section may improvelocal perfusion and/or metabolism. The short rectangular envelopes maycause effect similar to muscle blood pump. The increasing magnetic fluxdensity may increase efficiency of the muscle blood pump.

The continual application of the magnetic field to the muscle of thepatient may be up to 10 seconds, more preferably up to 5 seconds. Itshould be interpreted in the sense that a train of subsequent magneticpulses applied to the muscle of the patient may be up to 10 seconds. Ina preferred application a treatment duty cycle may be used.

The magnetic treatment may be combined with conventional treatment, e.g.treatment by optical waves.

Combined applications of optical waves and magnetic field may be used.The optical treatment may include treatment by optical waves. The magnettreatment may be provided by permanent magnets, electromagnetic devicesgenerating a static magnetic field or preferably by magnetic devicesgenerating time-varying magnetic field. In the preferred application themethod may combine treatment by a pulsed magnetic field and opticaltreatment. The application is not limited by the recited combination sothe combined method may include magnetic treatment and any treatment byelectromagnetic field such as radiofrequency waves, e.g. microwaves,short waves or long waves.

The basic parts of the optical irradiation system to apply the methodsof the present invention include a hardware panel and an optical wavesgenerating device or multiple optical waves generating devices. Theoptical waves generating device may be arranged in a pattern such as anarray or a matrix. The optical waves generating devices may be attachedto each other or alternatively be individually mounted on dedicatedsupports. A scanning system may also be one of the options.

An optical treatment device may include at least one energy sourceand/or connection to the energy source, a hardware panel for controllingthe optical treatment device and an optical waves generating device. Nonlimiting examples of optical waves generating device that may be usedinclude coherent or non-coherent optical waves generating devices, lightemitting diodes, lasers, laser diodes, different types of lamps andfiltered lamps or combinations thereof. The treatment device may includeat least one optical waves generating device, more preferably aplurality of optical waves generating devices of wavelength fromultraviolet, visible and infrared spectrum ranges. The wavelength may bein the range of 190 to 13000 nm, preferably in the range of 290 to 3000nm, more preferably in the range of 400 to 1500 nm, even more preferablyin the range of 550 to 1450 nm, particularly wavelengths about 915,1064, 1208 and 1715 nm may be used.

The plurality of optical waves generating devices may generate theoptical waves simultaneously at the same time. The plurality ofgenerated optical waves may interfere. Alternatively the plurality ofoptical waves generating devices may generate a plurality of independentoptical waves in different time, preferably in sequences. The pluralityof optical waves generating devices may be arranged in a predefinedpattern within an applicator, e.g. in an array or a matrix.

The optical waves generating device may be preferably external (e.g.hand-held), alternatively the optical treatment applicator may beintegral part of the optical treatment device (e.g. chair/bedimplemented). Additionally, optical delivery element, such as opticalwaveguides, light tubes or optical gel, may be used.

The at least one magnetic field generating device and the at least oneoptical waves generating device may be mutually oriented in one commonplane. Alternatively the at least one magnetic field generating deviceand the at least one optical waves generating device may be in twoplanes which may be parallel, perpendicular or mutually tilted. Theplanes may rotate.

The at least one magnetic field generating device and at least oneoptical waves generating device may include a common focus spot, i.e.the time-varying magnetic field and the optical waves may be applied tothe common area. The focus spot size may be in the range of 0.001 cm² to600 cm², more preferably in the range of 0.005 cm² to 300 cm², mostpreferably in the range of 0.01 cm² to 100 cm².

According to one exemplary embodiment the at least one magnetic fieldgenerating device may be surrounded by the at least one optical wavesgenerating device. The at least one optical waves generating device maybe tilted with respect to the magnetic field generated device or viceversa. The focus spot may be established by applying the magnetic fieldand optical waves simultaneously and/or separately.

The magnetic field generating device and the optical waves generatingdevice may have common center with respect to the applicator and/or tothe patient. Alternatively the distance between the center of magneticfield generating device and the center of optical waves generatingdevice may be in a range of 0.01 to 500 mm, more preferably in a rangeof in the range of 0.1 to 250 mm, even more preferably in the range of 1to 100 mm, most preferably in a range of 5 to 50 mm.

An area of all optical waves generating devices may be in the range of 4to 7900 cm², preferably in the range of 9 to 1950 cm², more preferablyin the range of 15 to 975 cm², most preferably in the range of 45 to 450cm².

The area of the magnetic field generating device and the area of opticalwaves generating device may differ. The area of the optical wavesgenerating device may in a range of 2 to 2000% of the area of themagnetic field generating device, more preferably in the range of 5 to1000%, even more preferably in the range of 10 to 500% of the area ofthe magnetic field generating device, most preferably in the range of 25to 250% of the area of the magnetic field generating device.

According to one exemplary embodiment the magnetic treatment and opticaltreatment may be provided by at least two separate devices, i.e. atleast one device for administering the magnetic treatment and at leastone device for administering the optical treatment. The opticaltreatment may be applied to target biological structure prior, after orwith some overlay with magnetic treatment. Alternatively opticaltreatment may be applied simultaneously with magnetic treatment. Thetime sequences of the treatments are described below.

FIG. 17 illustrates an exemplary embodiment providing combined treatmentby magnetic field and optical treatment. The optical treatment may beadministered by optical treatment device 62 (dotted line) including aconnection to an energy source 63 and a hardware panel 64 forcontrolling the optical treatment. The hardware panel 64 may beconnected with optical waves generating device 65 within an opticaltreatment applicator 66 (dotted line). The magnetic treatment may beadministered by magnetic treatment device 67 (dotted line) including aconnection to an energy source 68 and a hardware panel 69 forcontrolling the treatment by magnetic field. The hardware panel 69 maybe connected with magnetic field generating device 70 within a magnetictreatment applicator 71 (dotted line).

In an alternative embodiment the at least one optical waves generatingdevice may be in the treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

According to another embodiment the magnetic treatment and opticaltreatment may be provided by one device. The combined treatment providedby one device may be administered by at least one applicator. FIGS. 18aand 18b illustrate exemplary embodiments providing the combinedtreatment by two applicators providing different types of treatment,i.e. magnetic and optical treatment, to the patient. FIGS. 19a and 19billustrate exemplary embodiments providing the combined treatment by oneapplicator providing magnetic and/or optical treatment to the patient.

FIG. 18a illustrates one exemplary embodiment of combined treatmentdevice providing magnetic and/or optical treatment by at least twoapplicators. The combined treatment device 72 (dotted line) may includea connection to an energy source 73 providing energy for a magnetictreatment and for an optical treatment. The optical treatment may becontrolled by a hardware panel for optical treatment 74 which maycontrol an optical waves generating device 75 within an opticaltreatment applicator 76 (dotted line). The magnetic treatment may becontrolled by a hardware panel for magnetic treatment 77 which controlsa magnetic field generating device 78 within a magnetic treatmentapplicator 79 (dotted line).

In an alternative embodiment the at least one optical waves generatingdevice may be in the combined treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

FIG. 18b illustrates another exemplary embodiment of the combinedtreatment device providing magnetic and/or optical treatment by at leasttwo applicators. The combined treatment device 80 (dotted line) mayinclude a connection to an energy source 81 providing energy for themagnetic treatment and/or for the optical treatment. Optical and/ormagnetic treatment may be controlled by a hardware panel 82. Thehardware panel 82 may control an optical waves generating device 83within an optical treatment applicator 84 (dotted line). Further thehardware panel 82 may control a magnetic field generating device 85within a magnetic treatment applicator 86 (dotted line).

In an alternative embodiment the at least one optical waves generatingdevice may be in the treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

FIG. 19a illustrates still another exemplary embodiment of the combinedtreatment device providing magnetic and/or optical treatment by at leastone applicator. The combined treatment device 87 (dotted line) mayinclude a connection to an energy source 88 providing energy for themagnetic treatment and/or for the optical treatment. The opticaltreatment may be controlled by a hardware panel for optical treatment 89which may control an optical waves generating device 90 within anapplicator 91 (dotted line). The magnetic treatment may be controlled bya hardware panel for magnetic treatment 92 which may control a magneticfield generating device 93 within the applicator 91 (dotted line). Theapplicator may provide combined treatment.

In an alternative embodiment the at least one optical waves generatingdevice may be in the treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

FIG. 19b illustrates still another exemplary embodiment of the combinedtreatment device providing magnetic and/or optical treatment by at leastone applicator. The combined treatment device 94 (dotted line) mayinclude a connection to an energy source 95 providing energy for themagnetic treatment and/or for the optical treatment. Optical and/ormagnetic treatment may be controlled by a hardware panel 96. Thehardware panel 96 may control an optical waves generating device 90 andmagnetic field generating device 93 and/or a switching device operatingthe magnetic field generating device within an applicator 97 (dottedline).

In an alternative embodiment the at least one optical waves generatingdevice may be in the treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

According to still another exemplary embodiment the magnetic fieldgenerating device may be used as an energy source for providing energyto at least another part of the treatment device, e.g. an optical wavesgenerating device such as light-emitting diode (LED). FIGS. 20a and 20billustrate exemplary embodiments of the magnetic field generating devicewhich may be used as power supply. The magnetic field generating device98 may be surrounded by a conductor loop 99. The time-varying magneticfield generated by magnetic field generating device 98 may induce eddycurrents in the conductor loop 99 within proximity of the magnetic fieldgenerating device 98. The induced current in the conductor loop 99 maybe used for providing energy to another powered part of the treatmentdevice, particularly in the applicator, or another treatment device,such as at least one optical waves generating device. FIG. 20aillustrates an exemplary embodiment of magnetic field generating device98 surrounded by a conductor loop 99. The conductor loop 99 may beconnected to a plurality of optical waves generating devices 100. FIG.20b illustrates another exemplary embodiment of the magnetic fieldgenerating device 98 surrounded by the conductor loop 99. The conductorloop 99 may provide the energy to the optical waves generating device100. The optical waves generating device may be distanced from theconductor loop and may be external to the applicator including themagnetic field generating device 98 and the conductor loop 99.

Biocompatibility issues or hot spot generation may be overcome bytransmitting electromagnetic energy into the target biological structurewithout physical contact with the patient. Contactless application ofmagnetic and/or optical treatment may provide sufficient passive coolingof the biological structure by circulating air.

In some indications, it may be advantageous to treat deeper adiposetissue by magnetic field simultaneously with the treatment of moresuperficial layers of the skin by optical waves.

An air gap or bolus with high air permeability may be placed between theskin and the applicator. The bolus may be preferably transparent to theoptical waves. This arrangement may use the human thermoregulatorysystem for cooling and may avoid the need of artificial cooling of theskin. Optionally, the skin may be cooled via a stream of chilled orambient temperature air. The human thermoregulatory system may enableperspiration and other body fluids to evaporate and may cool thesurrounding skin. Sweat accumulation and/or hot spot creation may beavoided. Use of cooling fluids or gels may not be necessary but may beoptionally used. Cost of the treatment may be reduced and patientcomfort may be improved. The applicator may be in direct or indirectcontact with patient's skin. A bolus may be used for providing indirectcontact of the applicator with the target biological structure. A bolusmay be filled with a material, preferably a fluid, influencing thepropagation of the electromagnetic waves and/or homogenizing thetemperature distribution of the patient's skin. Alternatively the bolusmay deliver the electromagnetic waves to the target biologicalstructure, e.g. a waveguide.

Cooling may be provided by positioning an air moving device proximate tothe skin. The air moving device may be attached to or implemented intothe applicator. Air moving device may be any kind of fan, ventilator orblower. The blower may include an air tube connected to air source formoving air through the air tube to the patient's skin. The air sourcemay alternatively be cooled to provide cooled air. Alternatively, airsuction may be also used as an active cooling method.

Alternatively the treatment may be provided by moving at least oneapplicator. The movement of the applicator may be manual or automatic.The automatic movement may be random or the movement may follow apredetermined pattern, e.g. an array, a matrix or predefined trajectorydesigned for the selected treated part of the body. The predefinedmovement may be adjusted following the patient's needs. The movement ofthe applicator may be provided by an arm, which may be preferablyarticulated.

Constant movement of the applicator over a larger area may not beneeded. The applicator may remain in a stationary position relative tothe patient for several seconds or longer, e.g. for at least 10, 30, 60,120 or 240 seconds, or longer. The at least one applicator may be ofsuch dimension which may allow to the treated biological structure to bewithin physiological conditions, e.g. the biological structure may notbe overheated over critical temperature causing irreversible changes inthe biological structure.

One or more applicators may move in the vicinity of the patient's body.The movement may be provided in various speed and/or acceleration. Theapplicator may be moved in at least one direction, e.g. longitudinal,vertical, transversal or different axis and/or by rotational movementaround any direction. Plurality of applicators may move in synchronized,randomized and/or independent manner. At least one applicator of theplurality of applicator may be static.

The homogeneity of treatment may be provided by the movement of theapplicator. In one exemplary embodiment the applicator may move overand/or in different angle to the patient by rotational movement. Inanother exemplary embodiment the applicator may move in the vicinity ofpatient's skin. In still another exemplary embodiment the applicator maymove to focus the treatment.

The applicator may include at least one sensor for detecting thetemperature of the skin. The sensor may be preferably contactless.Alternatively the sensor may measure the temperature in contact manner.Alternatively, the skin impedance may be determined as well.

The sensor may be connected with at least hardware panel for controllingthe optical treatment to adjust the power flux density applied to thebiological structure to maintain the temperature of the targetbiological structure within treatment range. The temperature sensor alsoprevents the patient from any thermic damage.

Referring now to FIG. 21, in one embodiment the device includes base101, handheld applicator 114 and/or a scanning unit 102. Handheldapplicator 114 may be used for delivery of the optical waves from thebase 101 to the scanning device 102. Base 101 may include centralcontrol unit 104, user interface 105, optical waves generating device106 and/or calibration unit 107.

The central control unit 104 may change the treatment parameters and/orcontrol other parts of the device coupled to it. The method of operationmay include the central control unit 104 communicating with userinterface 105, optical waves generating device 106, power supply 102and/or calibration unit 107. The central control unit 104 may alsocommunicate with a scanning power supply 108, scanning optics 111,scanning control unit 109, movement assembly 110 and/or transmissionelement 112 located in the scanning unit 102. The scanning unit 102 mayfurther include a magnetic field generating device. The magnetic fieldgenerating device may communicate with the base 101.

Optical waves generating device 106 may comprise for example, a lightemitting diode, a laser emitting diode, a flashlamp, a tungsten lamp, anincandescent lamp, a mercury arc or any other light or optical wavesgenerating device known in the art. Optical waves generating device 106may generate coherent, incoherent, depolarized and/or polarized opticalwaves. Coherent monochromatic optical waves may include any type oflaser, for example, a chemical laser, a dye laser, a free-electronlaser, a gas dynamic laser, a gas laser (for example an argon laser orcarbon dioxide laser), an ion laser, a metal-vapor laser (for example agold vapor laser and/or a copper vapor laser), a quantum well laser, adiode laser (for example comprising GaAs, AlGaSbAs, InGaAsP/InPm InGaAs)and/or a solid state laser (for example a ruby laser, a Nd:YAG laser, aNdCr:YAG laser, an Er:YAG laser, a Nd:YLF laser, a Nd:YVO4 laser, aNd:YCOB laser, a Nd:Glass laser, a Ti:sapphire laser, a Tm:YAG laser, aHo:YAG laser or an Er,Cr:YSGG laser). Methods of operation may includeoptical waves generating device 106 communicating with user interface105, calibration unit 107 and/or central control unit 104. Optical wavesgenerating device 106 may also communicate with scanning optics 111,typically by providing the generated optical waves (for example light).

In an alternative embodiment the scanning unit may ewnable detachablecommunication with handheld applicator applying magnetic field.

The magnetic field generating device and the optical waves generatingdevice may move simultaneously. The simultaneous operation of themagnetic field generating device and the optical waves generating devicemay generate a common energy spot, i.e. an optical spot and a magneticspot.

User interface 105 may include an LCD panel or other suitable electronicdisplay. User interface 105 may be located on the base 101, handheldapplicator 114 and/or scanning unit 102. User interface 105 maycommunicate with optical waves generating device 106, central controlunit 104 and/or calibration unit 107. User interface 105 may alsocommunicate with scanning optics 111 and scanning power supply 108located in the scanning unit 102.

Calibration unit 107 may be controlled by central control unit 104.Calibration unit 107 may check stability of the output and/or wavelengthof the optical waves generating device 106. In case of instability,calibration unit 107 may provide one or more human perceptible signalsto the operator. The calibration unit 107 may also provide informationto the central control unit 106 which may adjust or correct one or moreparameters of the optical waves generating device 106. Calibration unit107 may check input or output parameters of the optical waves in thescanning optics 111, located in the scanning unit 102. Methods ofoperation may include the calibration unit 107 communicating with userinterface 105 and/or central calibration unit 104.

Calibration unit 107, optical waves generating device 106 and/or userinterface 105 may be positioned in or on base 101, handheld applicator114 or scanning unit 102.

Embodiments of devices of the present invention may include one or morescanning units 102 which may include scanning power supply 108, scanningcontrol unit 109, movement assembly 110, scanning optics 111, sensor 113and/or transmission element 112. In some embodiment, scanning unit 102may provide movement of the optical spot by changing one or morecharacteristics of the optical beam, including but not limited to thedirection or intensity of optical beam. A method of treatment mayinclude control of the scanning unit 102 through central control unit104 by the user interface 105. The scanning unit 102 may in someembodiments be positioned on an adjustable arm. The scanning unit may betilted to any angle with respect to the tissue. During some embodimentsof treatments using the system of the present invention, the scanningunit may remain in a set position and the optical spot may be moved bythe optics inside the scanning unit. In some embodiments, the scanningunit may move continuously or discontinuously over the body and providetreatment by one or more treatment patterns.

The scanning power supply 108 may provide electrical power to componentsof the present invention, including but not limited to scanning optics111, scanning control unit 109, movement assembly 110 and/ortransmission element 112. The scanning power supply 108 may be coupledto power supply 103. Alternatively, electrical power may be suppliedfrom the power supply 103 directly to some or all mentioned parts by thescanning power supply 108.

The scanning optics 111 may include one or more collimators, opticalwaves deflecting elements (e.g. deflecting mirrors), focusing/defocusingelements (e.g. lenses) and/or filters to eliminate certain wavelengthsof the optical waves. The scanning optics 111 may be controlledaccording to operator's needs through user interface 105. The scanningoptics 111 may be controlled by central control unit 104 and/or scanningcontrol unit 109. Both central control unit 104 and scanning controlunit 109 may control one or more parameters of the scanning optics,particularly of one or more deflecting elements. Parameters controlledmay comprise the speed of movement of one deflecting element, which maybe in the range of 0.01 mm/s to 500 mm/s, more preferably in the rangeof 0.05 mm/s to 200 mm/s, most preferably in the range of 0.1 mm/s to150 mm/s.

Scanning control unit 109 may control one or more treatment parameters.The scanning control unit 109 may communicate with central control unit104, scanning power supply 108, movement assembly 110 and/or scanningoptics 111. The scanning control unit 109 may be controlled throughcentral control unit 104 according to the operator's needs selected onthe user interface 105, or the scanning unit 102 may include anotheruser interface. In one embodiment, one or more functions of the scanningcontrol unit 109 may be assumed and/or overridden by central controlunit 104.

Movement assembly 110 may cause movement of one or more optical spots ontreated tissue. The movement assembly 110 may communicate with scanningoptics 111 and cause movement of one or more optical waves deflectingelements, which may be parts of the scanning optics 111. The movementassembly 110 may be controlled by central control unit 104 and/orscanning control unit 109. The movement assembly 110 may alsocommunicate with transmission element 112. The movement assembly 110 maycomprise one or more motors and/or actuators. The movement assembly 110may provide angular and/or linear movement to the optical wavesdeflecting elements of the scanning optics 111. In some embodiment, themovement assembly 110 may provide movement to the transmission element112.

The optical waves may leave the scanning unit 102 through thetransmission element 112. Transmission element 112 may be one or moreelements made from translucent material e.g. from glass or crystal withspecific optical properties, liquid solution including specific activesubstance modifying optic parameters and/or soft tissue reaction to thedelivered optical waves such as diamond, sapphire or transparentplastic. Transmission element may be connected to the movement assembly110, which may control focusing, defocusing, vertical or curvilinearmovement or tilting of the transmission element 112. Vertical movementof the transmission element 112 may be used for change of optical spotsize. Horizontal movement of the transmission element 112 provided bymovement assembly 110 may be used for change of optical beam deliveredto tissue. When the transmission element includes more elements madefrom translucent material, horizontal movement may be represented bymovement of separate element into the pathway to provide differentcharacteristic to the optical waves provided to tissue (e.g. focus,power output). Alternatively a wave guide may be used, e.g. a lightguide. Disclosed configuration may be used for application of more thanone optical beam to the tissue. Another configuration may includescanning unit including more than one transmission elements 112 coveredby coverings controlled by movement assembly 110.

The scanning unit 102 and/or handheld applicator 114 may include one ormore sensors 113, e.g. ultrasound sensor, gyroscope, Hall sensor,thermographic camera and/or IR temperature sensor.

FIG. 22a shows handheld applicator 114 containing body 206, opticalwaveguide 201, sensor 202 and/or translucent element 204. Flexibleoptical waveguide 205 may connect the handheld applicator 114 with thecase 101. Optical waveguide 201 may be encased by the body 206 and mayprovide optical path where the optical path leaves the handheldapplicator through the translucent element 204. Translucent element 204may be similar to transmission element 112 of the scanning unit 102.

FIG. 22b shows handheld applicator 114 coupled to zooming assemblyincluding lens 210, focusing mechanism 209, spacer 208 and emitters 203.The handheld applicator 114 may provide change of optical spot sizeaccording to movement of the lens 210. Lens 210 may be moved by focusingmechanism 209, which may be screwing mechanism. The zooming assembly mayinclude spacer 208, which may have length (i.e. from the tissue to thelowest lens position marked as 211) in range of 0.05 cm to 50 cm, morepreferably in the range of 0.1 cm to 35 cm, most preferably in the rangeof 0.15 to 10 cm.

The handheld applicator may include sensors 202 gathering informationfrom surroundings and/or emitters 203. Emitters 203 (e.g. magnet),located on scanning unit 102, may provide information to sensor 202(e.g. Hall sensor). Based on the emitted and recognized information, thecentral control unit may identify particular types of handheldapplicator of scanning unit. The recognition may by alternativelyprovided by RFID, data communication and other known methods. Thecentral control unit may enable treatment parameters according torecognized handheld applicator and scanning unit. Also, the centralcontrol unit 104 may limit treatment parameters according to recognizedzooming assembly and/or scanning unit 102. Sensors 202 together withemitter 203 may also ensure correct attachment of the handheldapplicator 114 with scanning unit 102 and/or zooming assembly. Method ofoperation may therefore include any human perceptible signal and/orcease of treatment (represented e.g. by shutting of the optical wavesgenerating device) when the attachment is not correct.

Handheld applicator 114 may be connected to the scanning unit 102 viaattaching mechanism. FIG. 23a shows separated handheld applicator 114from scanning unit 102. Handheld applicator 114 includes opticalwaveguide 201 guiding the optical waves (represented by arrow 212)encased in the handheld applicator's body 202. Furthermore it containsat least one pin 301. In shown exemplary embodiment, the handheldapplicator includes two pins 301. Shown part of the scanning unit 102includes recesses 302 ready for insertion of pins 301, connector 303,sealing element 304, at least one movement elements 305 (e.g. spring),scanning optical waveguide 306 and scanning optics 111. Movement element305 (e.g. spring) may be placed in dust-proof cylinder.

FIG. 23b shows connection of the handheld applicator 114 to the scanningunit 102 by connector 303. The sealing element 304 may be moved insidethe scanning unit 102 adjacent and/or to direct contact with scanningoptical waveguide 306. As a result, the sealing element 304 is the partof the newly created optical wave path including optical waveguide 201,translucent element 204, sealing element 304 and scanning opticalwaveguide 306. The optical waves 205 may be transmitted through thenewly created wave path of the scanning optics. The movement of thesealing element is provided by moving element 305 (shown as compressedsprings). Alternatively, the movement elements 305 may move the sealingelement 304 aside from the optical waveguide.

The handheld applicator is secured in the inserted position by theinsertion of the pins 301 to the recesses 302 creating locked pins 307.In exemplary embodiment, handheld applicator 114 may be rotated duringthe insertion into the scanning unit 102 until the pins 301 meet therecesses 302. During the release, rotating of the handheld applicator onthe opposing side may loose the locked pins 307 and the movementelements 305 may provide assisted release of the handheld applicator 114from the scanning unit 102. Alternatively the handheld applicator 114may be secured to scanning unit 102 by mechanism using magnetic forces,electromagnet, friction, latching or other know ways.

The sealing element 304 may be e.g. glass, diamond, sapphire or plastictightly positioned in the connector 303 in the dust-proof cylinder. Itmay provide dust-proof barrier to the scanning unit 102. Because it maynot be removed during the connection between the handheld applicator 114and scanning unit 102, it may prevent transfer of any contaminationand/or dust into the scanning unit 102.

The device and method may provide correct distance control. Correctdistance control may ensure the predetermined distance between thetreated tissue and scanning unit 102 and/or handheld applicator 114. Inan exemplary embodiment the distance may be measured by sound reflectione.g. by ultrasound transmitter and detector placed on and scanning unit102 and/or handheld applicator 114. Measured distance may be provided tothe central control unit 104 which may change one or more treatmentparameters according to measured distance. Ultrasound detector may alsomeasure temperature of the treated tissue and the central control unit104 may change one or more treatment parameters according to themeasured temperature.

Temperature of the treated tissue may be measured by thermographiccamera and/or IR temperature sensor. Measured temperature may becommunicated to the central control unit 104, which may then change oneor more treatment parameters according to measured temperature of thetreated tissue. Sensor measuring temperature may measure temperature asdifference between the beginning of the treatment and the current timeof the treatment. The sensor may also cooperate with calibration unit107 and provide values of real temperature of the treated tissue.

The magnetic treatment and treatment by optical waves may include but isnot limited to skin (including epidermis, dermis, hypodermis and/orbasement membrane), subcutaneous and/or visceral adipose tissue, bloodvessels, gingiva, tooth enamel, dentin, connective tissue, hairfollicles, hair papillae, pigmented lesion, muscle, cartilage, tendons,ligaments and/or sebaceous glands. Effects of treatments according topresent invention include but are not limited to topical stimulation ofthe biological tissue, healing, increased metabolism, analgesicreaction, bactericide, temporary increase of blood circulation musclerelaxation, fat elimination, thermal damage (e.g. ablation orcoagulation), necrosis, apoptosis, pigment damage, collagen damage,neocollagenesis, elastin damage, neoelastogenesis or damage ofconnective tissue.

Ablative laser skin resurfacing may cause thermal damage to theepidermis and/or dermis. On the other hand, non-ablative laser skinresurfacing may avoid thermal damage in the epidermis.

In one exemplary application the combined treatment may be used fortreatment including but not limited to Achilles tendonitis, ankledistortion, anterior tibial syndrome, arthritis of the hand, arthrosis,bursitits, carpal tunnel syndrome, cervical pain, dorsalgia,epicondylitis, facial nerve paralysis, herpes labialis, hip jointarthrosis, impingement syndrome/frozen shoulder, knee arthrosis, kneedistortion, lumbosacral pain, muscle relaxation, nerve repair,onychomycosis, Osgood-Schlatter syndrome, pain relief, painfulshoulders, patellar tendinopathy, plantar fasciitis/heel spur, tarsaltunnel syndrome, tendinopathy and/or tendovaginitis. Other applicationsmay include treatment of open wound.

Further applications of the combined treatment may be used for aestheticand cosmetic methods e.g. reducing the volume and/or number of adiposecells, sagging skin reduction, hyperhidrosis, cellulite treatment,elastin remodeling, elimination of stratum corneum, collagen remodeling,acne treatment, skin rejuvenation, body contouring, skin tightening,wrinkle removal, stretch mark removal, tattoo removal, treatment ofrhinitis or circumferential reduction. Embodiments of the presentinvention may be also used to treat vulvar laxity and/or hemorrhoids.Some embodiments are also capable of at least partial removal ofrosacea, dermatitis, eczema, café au lait spots, aphthous stomatitis,halitosis, birthmarks, port-wine stains, pigment stains, skin tumors,scar treatment and/or scar elimination, calcium deposits, herpessimplex, ulcers or other skin diseases classified by the WHO. Someembodiment of the present invention may also be used for generalsurgery, dentistry, stomatology or body modification e.g. scarification.

Treated parts of a human body may in some embodiments include, but arenot limited to, the face, neck, nose, mouth, arms, hands, torso, back,love handles, abdomen, limbs, legs, head, buttocks, feet and/or thighs.

The commonly targeted skin chromophores are hemoglobin, melanin, carbonor tattoo ink. Alternatively water may absorb the optical waves. Eachchromophore has unique absorption spectrum. The wavelength of theoptical wave should match one of the absorption peaks of the targetedchromophore. The lasers or laser diodes work usually in pulse regime inthese applications. The optical energy absorbed by the chromophore isconverted to thermal energy thereby destroying the targeted cells.Selection of the best adapted wavelength, power and pulse durationallows achieving optimal effect on targeted biological structure withminimal effect on surrounding tissue.

The application of optical treatment may be improved by application ofexogenous chromophores to the target biological structure. The exogenouschromophores may be applied in form of topical lotion, or may bedelivered to the target biological structure by micro-invasive orinvasive way such as injected.

According to the parameters of the optical waves used, different layersof the skin and different biological structures may be selectivelytreated. Various wavelengths, powers, pulse durations and repetitionrates of electromagnetic radiation are applicable to provide theadvantage of vast variability of penetration and absorption parameters.The operator may also adjust the optimum treatment time for eachwavelength and the time sequences of treatments by differentwavelengths, while some of them may overlap in time. In this way, atailor-made solution for each patient and each indication is available.The treatment may be highly selective to reduce or avoid damage of thesurrounding tissues.

Combinations of a plurality of optical waves generating devices allowperforming the treatment of plurality of target biological structures atthe same time and/or treating the same target tissue simultaneously bydifferent means, which optimizes the doses of radiation applied. Thisdiversification may also eliminate the risk of overheating, as theoptical treatment with parameters leading to no or negligible thermiceffect may be used. As a result, the risk of heat damage may beconsiderably reduced.

If the patient has more imperfections to be treated situated in the samebody areas, it is also possible to treat them simultaneously bydifferent types of electromagnetic waves. Each of the electromagneticwaves may be adjusted to optimum parameters for the target biologicalstructure imperfection treatment. Thus the time of patient and of theoperator is reduced, reducing the treatment cost.

The optical waves thermal effect may lead to temperature increase in thedermal and the sub dermal tissues also affects the triple-helixstructure of collagen fibers contained in such tissues. This may resultin remodeling and rejuvenation of collagen, increase of skin density anddermal thickening based on neocollagenesis. Skin tightening may also beachieved. In one aspect, the present methods selectively treat deephuman tissue containing low volume of water, such as adipose tissue.Optical energy is provided to the skin by optical waves generatingdevice. Remodeling and reducing the volume and/or number of adipocytesor skin tightening in the targeted areas may change the overallappearance of the body. Therefore it may be used for body contouring,body shaping and cellulite treatment.

Optical energy may be provided to the skin by at least one optical wavesgenerating device in pulse or continuous mode. Optical energy isprovided through the skin to the underlying dermal and/or subdermaltissue, without contacting the skin. The radiant energy may be convertedinside the target tissue to heat. The radiant energy enables treating ofthe adipose tissue and/or collagen tissue, accelerating apoptosis and/orcell lysis (e.g. adipose cell), based on amount of energy transmitted totarget biological structure. At the same time the triple helix structureof collagen fibers may result in remodeling and/or rejuvenation ofcollagen, increase of skin density and dermal thickening based onneocollagenesis. In an alternative embodiment the radiant energy enablestreating of target tissue resulting e.g. in neocollagenesis withoutadipose tissue reduction. Target tissue may be remodeled and/or reducedand body contouring and/or skin tightening effect may occur.

Cooling may also be used to modify and to optimally adjust the depth ofoptical radiation penetration. Light penetration may be enhanced ifcooling is used before phototherapy. The effects of heating in terms oflight penetration are the opposite.

In one aspect of the invention, cells may produce heat shock proteins inresponse to rapid changes of thermic conditions by applied alternationof cooling and treating by optical waves. It has been shown that heatshock proteins stimulate reparation processes in the cells. Theprinciples of cryolipolysis are also involved because adipocytes aremore susceptible to cooling than other skin cells. By alternating thesteps of cooling and treating, the apoptosis and/or cell lysis (e.g. ofadipose cells) may be considerably improved.

Optical treatment may treat the same or different skin layers as themagnetic treatment. As mentioned above, optical treatment may also beused for multiple rejuvenation and appearance enhancing applications.Another important indication is drug-free and addiction-free pain reliefin many conditions.

Non-limiting examples of optical therapies that may be preferably usedin combination with the treatment by magnetic field according to thepresent invention are: low level light therapy (LLLT), photodynamictherapy (PDT), high power laser therapy (HPLT) or intense pulsed light(IPL). However, the scope of the invention is not limited only to theseparticular optical irradiation methods. Other electromagnetic waves maybe used, e.g. a radiofrequency treatment.

Low-level light therapy may be one of the methods of non-invasiverejuvenation with no or a very small thermal effect. LLLT may beeffective throughout the visible, infrared and near ultraviolet spectrumranges. The term low level may refer the fact that the levels of energyor power densities may be low compared to other forms of light treatmentsuch as by lasers, which may be applicable for cutting, thermalcoagulation or thermal damage, such as ablation. Treatment energies inLLLT may be limited to 0.1-20 or a few J/cm² and/or by a power of 1 mWto 500 mW per optical waves generating device. The depth of penetrationof the low level light radiation may depend on parameters of the opticalwaves generating device such as wavelength, operating mode, which may bepulse or continuous, the power output, the probe design and thetreatment technique. The depth of penetration where the light still mayhave therapeutic effects should match the depth of the desired zone tobe treated. The penetration depth may be lower than in HPTL, up toseveral tens of mm approximately. Due to the low levels of absorbedenergy, the treated and surrounding biological structures may not beheated and may not be damaged. Although many wavelengths may be used, itmay be advantageous to use at least one beam in the visible spectrum sothat the area of application on the patient's body may be easilydetermined by the operator.

LLLT may use either coherent optical waves generating devices such aslasers or laser diodes or non-coherent light sources includingincandescent lamps, gas filled lamps, filtered lamps optimized for aparticular wavelength, light-emitting diodes, etc. A combination of anytypes of optical waves generating devices may be also used, as well as aplurality of optical waves generating devices of the same type.

The photons emitted by the low level optical waves generating devicesused in LLLT therapy may be absorbed by endogenous mitochondrialchromophores in skin. Consequently, many processes may be activated,e.g. electron transport, increased adenosine triphosphate (ATP)production, enhanced blood micro-circulation, collagen productionincrease, dermal matrix remodeling etc. LLLT may thus successfully treata multitude of conditions that may require stimulation of healing,acute/chronic pain relief or restoration of function. It has been provedthat LLLT may have beneficial effects on wrinkles, scars including acnescars, stimulating the scalp in hair treatment, healing of burns, skintightening, anti-oedematous effects, regeneration after sport etc.Inflammatory skin diseases such as psoriasis or acne may also be treatedby the proposed treatment. In pigmentation disorders such as vitiligo,LLLT may increase pigmentation by stimulating melanocyte proliferation.

LLLT may influence also reduction of number and/or volume of adiposecells. It is believed that the incident optical waves may producetransient pores in adipose cells, allowing lipids to leak out into theinterstitial space of adipose tissue. If the parameters are appropriate,the pores may close upon cessation of the energy application and thecell membrane may return to contiguity. The adipose cells may not bedestroyed, but temporary opening within the cell's membrane induced bythe optical waves may provide a pathway for lipid to exit the cell andin the end also the patient's body. It may lead to the reduction ofnumber and/or volume of adipose cells. This adipose cell number and/orvolume reduction may restore proper adipose cells function therebyacting as an anti-diabetes mechanism.

It may be advantageous to combine LLLT and magnetic treatment for safeand efficient target biological structure treatment.

While in LLLT the light may be absorbed by endogenous cellularchromophores, PDT may be based on introduction of exogenousphotosensitizers into the cells which may be then irradiated withwavelengths of visible or near infra-red light. Photosensitizer drugsmay become activated by one or several types of optical waves. Theoptimal type of optical waves may depend on the target biologicalstructure and the absorption peak of the particular chromophore drugused. PDT optical waves generating devices may include laser, intensepulsed light, light-emitting diodes or many visible lights includingnatural sunlight, etc.

Unlike LLLT HPLT may cause thermic effects on the skin. HPLT lasershaving an output of 500 mW or greater may be used for this treatment,with energy densities greater than 10 J/cm². High power may allowextremely high penetration of the optical waves, in order of tencentimeters or even more, ensuring that the right dose actually reachesthe target biological structure localized deep in the tissue. Laser maybe precisely adjusted due to its monochromacy and coherency. Thereforeits propagation and targeted biological structure may be finelypre-defined. Research shows that biological structures treated by HPLTmay be irradiated to increase production of adenosine triphosphate(ATP). Similarly to LLLT, the biological responses to increased ATPproduction may include reduction of inflammation, reducing scars,increased cell metabolism, improved vascular activity, and acceleratedhealing. It may improve regeneration after sport. Significantimprovements of many post-traumatic pathologies or osteoarthritis havebeen noted, as well as temporary relief of stiffness and muscle spasms.It may be important to note that HPLT also may provide the patients withdrug-free and addiction-free acute and/or chronic mediation of pain, bydecreasing inflammation and/or swelling and by increasing the release ofendorphins and enkephalins. Moreover, if pulse regime is applied, thewavelength-specific photomechanical wave generated in the tissue maystimulate free nerve endings, thus blocking pain pathways in the nervoussystems and bringing immediate pain relief.

High power lasers, laser diodes or intense pulse light sources (IPL) maybe also used for treating pigmented targets in the skin by selectivephotothermolysis. Such high power lasers reaching sufficient powerdensity to vaporize illuminated cells may be gas lasers such as CO2 orexcimer laser, solid-state lasers such as rubin, Nd:YAG or Er:YAG laser,semiconductor lasers, dye lasers such as Rhodamin 6G laser etc.

The indications may include e.g. vascular lesions, varicose veins, acne,pigmented lesions and mole marks or tattoos.

Similar principles may also be used for removal of excessive body hair.Light pulses may target the hair follicle causing the hair to fall outand minimizing further growth. Alternatively, light may be delivered totarget biological structure continuously.

IPL may be used also for some other skin treatments with therapeutic orrejuvenating effects, sharing some similarities with high power lasertreatment. In both cases, optical waves may be used to destroy thetarget by treating. But unlike lasers using a single wavelength of lightwhich may typically match only one chromophore, and only one condition,IPL may use a broad spectrum of wavelengths. When used with filters, itmay be adapted to treat various conditions. This may be achieved whenthe IPL operator selects the appropriate filter that may match aspecific chromophore. Such filter may be represented by an opticalmaterial filtering e.g. 480 nm, 530 nm, 560 nm, 640 nm or 690 nm.

The optical energy flux density of the IPL treatment may be in the rangeof 1 and 50 J/cm², preferably in the range of 2 to 40 J/cm², morepreferably at least 5 J/cm², or up to 100 J/cm². The optical waves maybe applied continually or in pulses. Pulse width may be time durationthat the target is exposed to the optical waves. Pulse width may bemeasured in miliseconds. Pulse width may be shorter than thermalrelaxation time of the target, i.e. the pulse width may be long enoughto allow heating of the target but also short enough that the target maybe able to cool so that there may be no heat buildup in surrounding skinand tissue. The pulse width may be in the range of 1 to 300 ms,preferably in the range of 5 to 50 ms, most preferably up to 30 ms.

According to one application a combined treatment by optical waves andmagnetic field may be used for treatment of pelvic floor area disorders,e.g. gynaecologic and/or urologic issues such as incontinence, ormenorrhagia. One exemplary application may be inserting the optical wavegenerating device into the body cavity, e.g. a vagina. The opticaltreatment may selectively raise a temperature in the vagina to providetightening effect. A suitable probe may be used for inserting theoptical waves generating device. The target biological structure may betightened due to increased temperature and/or improved collagenesis.Alternatively the optical wave generating device may be external to thebody cavity and the optical waves may be delivered to target tissue byoptical delivery element.

An exemplary application of combined treatment by optical waves andmagnetic treatment may be application to enhancing appearance ofgenitalia, e.g. external female genitalia such as labia minora, labiamajora and/or clitoris. Furthermore collagenesis may be improved invagina hence it may be smoother and/or firmer. Therefore the combinedtreatment may enhance physical pleasure during coitus.

Optimal wavelength of the optical waves may be in the range of 400 to600 nm, particularly around 500 nm. Energy density may be up to 25J/cm², more preferably up to 10 J/cm², most preferably in the range of 1to 8 J/cm². Treatment may be administered in continual or preferably inpulsed mode.

The magnetic treatment may be targeted to the area of pelvic floor totreat pelvic floor muscles. The repetition rate of the magnetic pulsesmay be in the range of 1 to 150 Hz, preferably up to 100 Hz, morepreferably in the range of 5 to 70 Hz, e.g. at least 30 Hz.Alternatively the optical treatment may provide biostimulation effect topromote neocollagenesis. The tightening effect may be also promoted byat least muscle contraction. Hence the treatment of incontinence may beprovided by different energy types. The collagenesis may be improved byapplication of magnetic treatment improving local metabolism by improvedblood flow and/or at least muscle contraction.

According to one application a combined treatment by optical waves andmagnetic field may be used for treating a pain. The pain relievingeffect may be combined and significantly improved due to differentapplied energies and different approaches of relieving the pain. Thepain relief is drug-free and may last up to several hours after thetreatment. The pain relieving may be applied for treatment of chronicand/or acute pain. Alternatively, the pain relieving effect caused bymagnetic and/or optical treatment may be used for improvingacceptability of optical treatment provided by high power densityoptical radiation, e.g. high power laser or IPL. The repetition rate ofmagnetic pulses is at least 100 Hz, more preferably at least 140 Hz.

According to one application a combined treatment by optical waves andmagnetic field may be used for myorelaxation effect. High efficientrelaxation may be caused by combined influence optical and magnetictreatment on the biological structure. The target biological structuremay be relaxed by optical treatment, e.g. by increased temperature ofthe target biological structure, and by magnetic treatment usingrepetition rate of the magnetic pulses of at least 100 Hz, preferably atleast 150 Hz or at least 180 Hz.

According to one application a combined treatment by optical waves andmagnetic field may be used for adipose cells reduction. The adiposecells may be heated by the optical treatment above 37.5° C., morepreferably above 40° C., most preferably in the range of 40 and 50° C.,or up to 60° C. The temperature increase may induce apoptosis and/ornecrosis of the adipose cells. The apoptosis of the adipose cells may bepreferred effect due to reduced risk of inflammation and/or panniculitisoccurrence. The temperature increase may also liquefy the adiposetissue. The magnetic treatment may contribute the optical treatment byinducing the at least muscle contraction which may improve the localblood and/or lymph circulation and/or local metabolism. Hence the deathadipose cells may be removed faster from the human body. The apoptosisof the adipose cells may be also contributed by the influence of themagnetic treatment to metabolism of Ca ions as was described before. Theoptical waves may be in visible or in IR spectrum such as near-IRspectrum, e.g. in the range of 600 to 1500 nm in a plurality ofapplicable bands e.g. in the range of 635 to 680 nm, particularly 658nm; or in the range of 780 to 980 nm, particularly 800 nm or 940 nm; orin the range of 1050 to 1100 nm, particularly 1060 nm due to relativelyhigh penetration through the skin. Alternatively the optical waves maybe in the range of 1300 to 1450 nm, particularly 1320 and 1440 nm may beapplicable. Alternatively wavelength of 2940 nm may also be used.

The optical treatment may last up to 120 minutes, preferably in therange of 1 to 60 minutes, more preferably in the range of 20 to 40minutes. The treatment time may be dependent on BMI of the patient. Thepower flux density of the optical treatment may be up to 50 W/cm²,preferably up to 25 W/cm², more preferably in the range of 1 to 15W/cm², most preferably in the range of 2 to 10 W/cm² such as at least 5W/cm². In the preferred application power modulation may be used.

The above mentioned methods may be combined and the improved treatmenteffect may be induced. The treatment results may be achieved in shortedtime period and may be more significant.

According to one application a combined treatment by optical waves andmagnetic field may be used for cellulite treatment. Optical waves maypenetrate the skin and increase the temperature of adipose cells andthermally damage the adipose cells. Hence the optical treatment may beused for reducing number and/or volume of adipose cells, remodelingtreated body parts, or improving the skin appearance. The targetbiological structure, e.g. adipose cells, may be exposed to increasedtemperature. The temperature may be in the range of 37.5 to 60° C., morepreferably in the range of 40 to 50° C., most preferably in the range of42 to 47° C., or up 80° C. The damaged adipose cells may be removed byblood and/or lymphatic system to be metabolized. The heat generated inthe target biological structure may induce a production of growthfactors and/or fibroblasts which may improve collagen neogenesis and/ornew vein formation to support the newly generated collagen formations.

The adipose cells may be influenced by apoptosis and/or necrosis.Alternatively the adipose cells may be liquefied. The adipose cellsmetabolism may be contributed by the at least muscle contraction.Furthermore the application of optical treatment may heat the fibrousseptae of the cellulite. The heated septae may be straightened by the atleast muscle contraction caused by the magnetic treatment. Further theat least muscle contraction may remove the water from the cellulitetissue to reduce the cellulite. Therefore more significant results maybe achieved in shorter time periods. The above mentioned methods may becombined hence the enhanced effect may be induced. Hence the results maybe achieved in shorted time period and may be more significant.

Optimal wavelength should include low absorption within the skin, i.e.low absorption of water and/or melanin, and high absorption within theadipose cells. The optical waves may be in visible or in IR spectrumsuch as near-IR spectrum, e.g. in the range of 600 to 1500 nm in aplurality of applicable bands e.g. in the range of 635 to 680 nm,particularly 658 nm; or in the range of 780 to 980 nm, particularly 800nm or 940 nm; or in the range of 1050 to 1100 nm, particularly 1060 nmdue to relatively high penetration through the skin. Alternatively theoptical waves may be in the range of 1300 to 1450 nm, particularly 1320and 1440 nm may be applicable.

The optical treatment may last up to 120 minutes, preferably in therange of 1 to 60 minutes, more preferably in the range of 20 to 40minutes. The treatment time may be dependent on BMI of the patient. Thepower flux density of the optical treatment may be up to 50 W/cm²,preferably up to 25 W/cm², more preferably in the range of 1 to 15W/cm², most preferably in the range of 2 to 10 W/cm² such as at least 5W/cm². In the preferred application power modulation may be used.

Optionally, an active cooling may be included. However, in many cases,auto thermoregulation by sweating may be sufficient. The active coolingmay be administered in continual mode or in pulsed mode to maintain theskin temperature within physiologic temperature, i.e. around or below37° C.

According to one application a combined treatment by optical waves andmagnetic field may be used for body shaping and/or improving muscletonus. According to one application, the muscle may be treated by theoptical treatment to increase the temperature of the muscle. Afterwardsthe heated muscle may be treated by magnetic treatment. The magnetictreatment may achieve more significant results due to increasedtemperature of the muscle. The muscle may be toned and/or strengthenedmore effectively. The toned and/or strengthened muscle may induce bodyshaping effect to enhance visual appearance of the treated body part.Moreover the results may be achieved without hours spent by exercisingof the muscle which may achieve unpredictable results within differentbody parts. The effectiveness of the magnetic treatment may be enhancedby preheating of the muscle by optical treatment. Magnetic treatment maybe provided at repetition rate of at least 0.1 Hz, more preferably atleast 5 Hz, even more preferably at least 20 Hz, most preferably atleast 50 Hz, or up to 700 Hz. The magnetic treatment may be preferablymodulated.

The above mentioned methods may be combined and the improved treatmenteffect may be induced. The treatment results may be achieved in shortedtime period and may be more significant.

According to one application a combined treatment by optical waves andmagnetic field may be used for focused treating of specific musclestructures, e.g. buttocks. The demand for enhancing visual appearance ofthe buttocks has rapidly increased during last few years. The combinedtreatment may enhance the visual appearance of the buttocks by thermaleffect caused by optical treatment and/or by muscle exercising effect byfocus magnetic treatment. The magnetic treatment may be selectivelyfocus to enhancing the visual appearance of the buttocks by shreddingand/or toning of the buttock muscles such as gluteus maximus, mediusand/or minimus.

Alternatively the combined focused treatment may be used for causingbreast lifting effect by preheating effect of the Cooper's ligament andfollowing magnetic treatment with increased effectiveness. The treatmentmay lift the breasts up.

The above mentioned methods may be combined and the improved treatmenteffect may be induced. The treatment results may be achieved in shortedtime period and may be more significant.

According to one application a combined treatment by optical waves andmagnetic field may be used for skin rejuvenation. The optical treatmentmay be applied to cause micro-damages within the skin to promote theincrease production and/or regeneration of collagen fibers. It mayinduce the enhanced visual appearance of the skin which may lookwell-toned, smoother and/or firmer. The optical treatment may becontributed by magnetic treatment causing at least muscle contractionwhich may induce the increase local metabolism and/or blood circulation.Hence the sufficiency of nutrients may be delivered to the targetbiological structure to promote its regeneration and/or productionprocess.

Optical waves providing biostimulation effect may be of wavelength inthe range of about 400 nm to 1200 nm, more preferably in the range from440 to 1100 nm most preferably in the range from 450 to 1000 nm. Opticalwaves providing biostimulation effect may be coherent, non-coherent,monochromatic and/or polychromatic.

The above mentioned methods may be combined hence the enhanced effectmay be induced. Hence the results may be achieved in shorted time periodand may be more significant.

According to one application a combined treatment by optical waves andmagnetic field may be used for treating the scars and/or stretchmarks.The optical treatment may enhance the visual appearance of scars and/orstretchmarks by providing improved the growth of collagen and/or elastinfibers to provide the skin younger, firmer and/or smoother appearance.The optical treatment may induce micro-damages to collagen and/orelastin fibers to promote their regeneration and/or production. Theoptical treatment may be contributed by magnetic treatment causing atleast muscle contraction which may induce the increase local metabolismand/or blood circulation. Hence the sufficiency of nutrients may bedelivered to the target biological structure to promote its regenerationand/or production process. Furthermore the at least muscle contractionmay straighten the newly produced collagen and/or elastin fibers bymassaging effect.

The parameters of optical treatment may be similar as used for wrinkletreatment.

The above mentioned methods may be combined and the improved treatmenteffect may be induced. The treatment results may be achieved in shortedtime period and may be more significant.

According to one application a combined treatment by optical waves andmagnetic field may be used for treating the wrinkles. The opticaltreatment may remove the wrinkles by resurfacing of the skin. Differentwavelength may promote the growth of collagen and/or elastin fibers toprovide the skin younger, firmer and/or smoother appearance. The opticaltreatment may be contributed by magnetic treatment causing at leastmuscle contraction which may induce the increase local metabolism and/orblood circulation. Hence the sufficiency of nutrients may be deliveredto the target biological structure to promote its regeneration and/orproduction process.

According to one application a combined treatment by optical waves andmagnetic field may be used for lip visual appearance enhancing effect.The optical treatment may improve the growth of collagen and/or elastinfibers to provide younger, fuller, firmer and/or smoother appearance.The optical treatment may be contributed by magnetic treatment causingat least muscle contraction which may induce the increase localmetabolism and/or blood circulation. Hence the sufficiency of nutrientsmay be delivered to the target biological structure to promote itsregeneration and/or production process.

The above mentioned methods may be combined and the improved treatmenteffect may be induced. The treatment results may be achieved in shortedtime period and may be more significant.

All the above mentioned methods may be used in various time sequences ofoptical and/or magnetic treatment. The major time sequences aredescribed below.

Alternatively, the application of optical waves may provide disinfectioneffect. Such application may include application of UV light, e.g. UV-Band/or UV-C light. The wavelength of the optical waves may be in therange of 200 to 300 nm, most preferably in the range of 250 to 270 nm.The optical radiation may destroy the DNA of microorganisms such asbacteria, or virus. The nucleic acid in DNA may form a covalent bond(such as thymine dimer) preventing unzipping process during reproductioncycle. Hence the replication ability of the microorganism is disabledand the microorganism may die and the infection may be treated. Thepower density may be up to 300 mW/cm², preferably up to 200 mW/cm², orin the range of 1 to 50 mW/cm², more preferably in the range of 5 to 25mW/cm². In one exemplary application the UV light may be in externalflow-chamber to provide disinfected air to the treated area.

Similar application of optical waves may be used for cleaning the skinof the patient.

Another application of optical treatment may be treatment of fungalinfections of nails and/or skin. Non-limiting examples of theseinfections may be athlete's foot, jock itch, ringworm or yeastinfection. The skin and/or the nail suffering from these infections maychange a color, get thicker or it may hurt. The infection may be treatedby optical radiation. Additionally, a pain may be relieved by theoptical treatment.

The method of treatment may include treatment of one or more treatmentareas by one or more treatment patterns. Treatment of the treatment areaby one or more treatment areas may be repeated more than one time.Treatment area may be defined as an area where the optical spot is movedduring treatment session, together with surroundings of this area.Treatment pattern may be defined as shape of resulting surfacetrajectory of the optical spot on the treatment area during onetreatment cycle. The method of treatment during may include followingsteps:

Method of treatment may include following steps: choosing of body partto be treated; mapping of the tissue problem by the sensor; proposingand modification of shape and dimensions of one or more treatment area;selection of shape and dimension of one or more treatment patterns;setting of threshold values of treatment parameters; setting ofthreshold ranges; choosing of treatment mode; optical waves transfer tothe tissue; measuring of treatment parameters and/or specifications ofthe tissue problems (e.g. color, shape and/or depth); response tomeasurement.

Order of the steps may be changed. One or more steps may be omittedand/or multiplied.

Body part to be treated may be chosen by patient, operator and/ordevice. Patient and/or operator may choose the body part because ofesthetic or medical reason. Device may choose the body part according toinformation from one or more sensors. For example, the ultrasound sensormay provide information about thickness of adipose tissue and/or cameramay provide information about presence of esthetic problems (e.g.cellulite).

Mapping of the tissue problem may be provided by camera and/orultrasound sensor. In case of camera, tissue problem may be recognizedby comparing the colors in the treatment area with the color ofreference tissue area. In case of ultrasound sensor, tissue problem maybe recognized by comparing the parameters (e.g. amplitude, frequency,period and/or reflection angle) of reflected mechanical wave oftreatment area with the parameters of reflected wave of reference tissuearea. Reference tissue area may be untreated tissue area chosen by theoperator and/or device. Color and/or parameters of reflected mechanicalwave may be measured before and/or after the mapping. The color and/orparameters of the reference tissue may be measured during the mapping bythe same sensor and/or different sensor.

Shape and dimension of the treatment area may be selected separately.Shapes may be selected from predefined set of shapes or the shape may becreated by the operator and/or device. Additionally, shape may beproposed by device according to chosen body part. Shape of treatmentpattern may be created according to the picture of the tissue problemcaptured by camera. After the selection, shape may be further modifiedby operator and/or patient by dividing the shape into plurality ofsegments (e.g. smaller surface parts and/or borderlines) and theirmovement to another shape. The creation of new shape, change of one ormore dimensions, division of created shapes and/or movement of segmentsmay be executed using the user interface 106. Dimensions of thetreatment area may be in the range of 1×1 cm to 180×180 cm and may havearea from 1 cm² to 32 400 cm², 15 000 cm², 10 000 cm² or 2500 cm².Dimensions of the treatment pattern may be in the range of 0.01 cm² to5000 cm² or 0.1 cm² to 2000 cm² or 1 cm² to 500 cm².

Examples of treatment patterns on the tissue surface shown on FIG. 24are linear vertical 401, linear horizontal 402, linear diagonal 403,circular 404, rectangular 405, spiral 406, zigzag 407, tooth-like shape408 and/or S-shape 409. Treatment pattern may be delivered in definedpoints and/or intervals, as shown on objects 410 and 411. Alternativelythe treatment patterns may be created by optical inside the tissue.

FIG. 25a shows treatment area 501 with treatment pattern 502. Treatmentpattern 502 is shown to be large surface pattern, which may be allowedby absence of any substantial unevenness. FIG. 25b shows treatment area501 with unevenness 502 and three treatment patterns 503 a-c contactingeach other.

Setting of threshold value may include choosing one or more thresholdvalues of one or more treatment parameters for determining othertreatment parameters. Threshold value may be temperature of the treatedtissue. Alternatively, the threshold value may be distance between thetissue and scanning unit or handheld applicator, total output of theoptical waves to at least part of the treated tissue area, optical fluxtransferred to at least part of the treatment area, scanning speed ofthe scanning unit 102 and/or handheld applicator 114. Method may includeincreasing of one or more threshold values until the patient and/oroperator stop the increase. During the increase of the threshold valuethe central control unit 104 may adapt at least one treatment parameterto increasing threshold value. The threshold value may be set beforetreatment or it may be changed during treatment according to measuredparameters by sensor 113 (e.g. distance and/or temperature of thetreated tissue). When the one or more threshold values of treatmentparameters are set, other treatment parameters may be adapted by device.

Setting of threshold ranges may include setting of ranges around thethreshold value, which may be about 25%, more preferably 20%, even morepreferably about 15%, most preferably 10% around the threshold value.Method may include setting of ranges of other treatment parameters,which have no set threshold value. Such range may preventnon-homogeneity of treatment.

Choosing of treatment modes is related to interchangeability oftreatment provided by scanning unit 102 and manual treatment provided byhandheld applicator 114. Large treatment areas without any unevennessmay be treated by using scanning unit 102 while treatment areas withunevenness may be treated by handheld applicator 114. Scanning unit 102may however be used to treatment of treatment area with unevennessbecause device may include adjustment of treatment parameters accordingto other steps of the method. It may be possible to combine use ofscanning unit 102 with handheld applicator 114. For example, treatmentpattern 502 on FIG. 25a may be provided by scanning unit 102, whiletreatment patterns 503 on FIG. 25b may be provided by handheldapplicator 114. The operator may use scanning unit for treatment oflarge areas of the tissue while the handheld applicator may be used fortreatment of the areas not affected by the scanning unit. The change ofthe handheld applicator to more effective scanning unit by connection ofthe former to the latter provides the operator versatile device forcomplex treatment. Both modes of treatment may be provided by onedevice.

Optical waves transfer to the tissue may include irradiation of thetissue by the optical waves. Also, camera may provide information aboutposition of the optical spot on the surface of tissue.

Measuring of treatment parameters and/or specifications of the tissueproblem may include measurement provided by one or more sensors 113.Treatment parameter may be measured continually or in distinct timeintervals. Also, the measuring may include processing of themeasurement, preferably by providing the information from the sensor 113to central control unit 104. Sensor 113 may measure treatment parameterwith set threshold value and/or threshold range. Measurement of thetissue temperature may be done by temperature sensor and measured tissuetemperature may be communicated to central control unit 104. Measurementof the specification of the tissue problem may include measurement ofits color, shape, depth and/or temperature on the edge of the tissueproblem. Specification of tissue problem may be measured by cameraand/or ultrasound sensor in similar way as the mapping of the colorirregularity.

Response to measurement of treatment parameters may include continuationof treatment, providing human perceptible signal, setting of newthreshold value and/or threshold range, cease of treatment, adjustmentof one or more set treatment parameters to set threshold in order to bein the range. For example, when the temperature of the treated tissue isout of threshold temperature range, the central control unit 104 maycease the optical waves transfer and/or change one or more treatmentparameters (e.g. optical spot size, optical spot shape, duration of thetreatment, optical waves output, direction of the movement of theoptical spot and/or scanning speed) in order to bring the temperature ofthe treated tissue back to the set threshold value and/or inside thethreshold range.

In another example, the set threshold value may represent the distanceof the treated tissue from scanning unit or handheld applicator. Becausethe presence of unevenness on the treated tissue may bring the scanningunit and/or handheld applicator closer to the treated tissue, theresponse may include adjust the distance in order to keep the actualdistance as close as possible to the set threshold value, provide humanperceptible signal, cease the treatment and/or change one or moretreatment parameters (e.g. optical waves output and/or optical spotsize) in order to compensate for change of distance. Change of one ormore treatment parameters may lead to change of threshold value. Changeof one or more treatment parameters according to distance of treatedtissue from scanning unit or handheld applicator may be advantageous fortreatment of less approachable curved parts of the body (e.g. flanks,legs and/or hips).

In still another example two threshold values representing thetemperature of the treated tissue during the treatment and distancebetween the tissue and scanning unit or handheld applicator may be set.When the temperature of treated tissue and the distance are differentfrom the set threshold values (e.g. because of the presence ofunevenness or non-homogeneity of optical waves generating device), theresponse may include cease of operation, human perceptible signal,change of one or more treatment parameters (e.g., optical waves output,optical spot size, scanning speed, direction of the movement of theoptical spot, treatment pattern, wavelength of the optical waves,frequency and/or optical flux) in order to bring the measured parametersof the treated tissue closer to the set threshold values and/or into theinterval provided by threshold ranges.

Response to measured specification of the tissue problem and may includecease of treatment and or change of more treatment parameters. Forexample, response may include decreasing of scanning speed, change oftreatment pattern and/or repeated movement of the optical spot over thetissue problem when the tissue problem retains the color duringtreatment. In another example when the optical spot is moved todifferently colored part of tissue problem (e.g. tattoo), the wavelengthof the applied optical waves may be changed e.g. in order to providetreatment to differently colored pigment and/or ink. In still anotherexample response may include change of output of the power, optical spotsize, wavelength of the optical waves and/or distance between tissue andscanning unit when at least part of the tissue problem is located deeperthan anticipated during initial mapping of the tissue problem. In stillanother example response may include change of treatment patterntogether with change of wavelength of applied optical waves. In suchcase, when the color of already treated tissue problem changes duringand/or after the treatment, the optical spot may be repeatedly movedover the tissue problem, while the applied optical waves has differentwavelength matching the different color of the tissue problem.

Response to changing and/or unchanged shape of the tissue problem mayinclude cease of treatment and/or change of one or more treatmentparameters. For example, when the shape of the tissue problems ischanged, the treatment parameter and/or optical spot size may be changedin order to match newly shaped tissue problem. Also, the output power ofthe optical waves and/or scanning speed may be changed.

Method of treatment may further include cease of operation of the deviceand/or provide human perceptible signal according to the informationfrom ultrasound sensor and/or gyroscope if error occurs. Error may bemovement of the patient sensed by ultrasound sensor. The error may be achange of distance between scanning unit and tissue. The event may bechange of position of the scanning unit itself sensed by gyroscope.Ultrasound sensor and/or gyroscope may then provide such information tocontroller. The controller may process the information and cease theoperation of device and/or provide human perceptible signal (e.g. sound,change of scanning color).

Other sensor 113 may be the sensor measuring oxygenation of the blood.Oxygenation sensor which may be contact or preferably noncontact and itmay be e.g. invasive Clark electrode, RGB camera, spectrophotometer, oneor more CCD cameras with specific filters (e.g. 520 nm and/or 660 nm)may provide information about blood flow and healing of the tissue. Theoxygenation of the tissue may also be measured by diffuse correlationspectroscopy flow-oximeter. Method may include measurement ofoxygenation of the blood in blood vessels in and/or close to thetreatment area. Measurement of oxygenation of the blood may be executedin blood vessels in and/or close to the treatment pattern. Oxygenationsensor may provide information to the central control unit 104. Thecentral control unit 104 may include proportional controller which maycease the transfer of optical waves when the blood oxygen level dropbelow oxygenation limit having value of 98%, more preferably 96.5%, mostpreferably 95%. Also, the central control unit 104 may include PD and/orPID controller which may adjust one or more treatment parameters. Whenthe blood oxygen level drops below the limit, operation may be ceased,optical waves output may decrease and/or increase, wavelength may bechanged and/or optical waves generating device may be changed. Opticalwaves output may be decreased for decrease of temperature and/or levelof tissue damage (e.g. ablation, coagulation). Change of wavelength mayinclude change to wavelength of or close to red light, which may enhanceblood oxygenation. Also, the response may include change of one or moreother optical treatment parameters.

The energy distribution of the optical waves in time may have triangularshape shown on the FIGS. 26a -c. As shown on the FIG. 26a , triangledistributions may follow closely to each other. Alternatively, as shownon FIG. 26b , the triangle distributions may be separated from eachother by intervals 601 of same and/or different length. Shown energydistribution is achieved by multiple steps of increase and decrease,wherein the overall steps create triangular shape, as shown on FIG. 26c.

Method of treatment may include autonomous treatment provided by thedevice including following steps choosing of body part to be treated;mapping of the tissue problem by the sensor; proposing and automaticmodification of shape and dimensions of one or more treatment area;selection of shape and dimension of one or more treatment patterns;setting of threshold values of treatment parameters; setting ofthreshold ranges; choosing of treatment mode; transfer of optical wavesto the tissue; measuring of treatment parameters and/or specificationsof the tissue problems (e.g. color, shape and/or depth); response tomeasurement.

Method of treatment may include autonomous treatment. When theautonomous treatment is provided, almost all steps of the treatment maybe provided by the device. Choosing of body part to be treated may beexecuted by operator and/or patient. All other steps including proposingand automatic modification of shape and dimensions of one or moretreatment area, selection of shape and dimension of one or moretreatment patterns, setting of threshold values of treatment parameters,setting of threshold ranges, transfer of optical waves to the tissue,measuring of treatment parameters and/or specifications of the tissueproblems and/or response to measurement may be provided autonomously bythe device, where the method may include correction and/or modificationof the operation by device itself according to the measured informationfrom the sensors.

Method of treatment may include semiautonomous treatment. When thesemiautonomous treatment is provided, the device may provide autonomoustreatment with possible correction and/or modification of its operationby the operator and/or patient during the treatment. The correctionand/or modification of the operation may be done according to themeasured information from the sensors, patient's needs and/or operator'sneeds.

The method of treatment may include of time-shifted optical waves (e.g.second laser). The scanning unit 102 may include crystal located in theway of the propagation of the second laser beam, which may causetime-shift of optical waves propagation. The time-shifted laser opticalwaves may be transmitted later than the first laser. Therefore the bothlasers, particularly in pulse mode, may treat same optical spot (i.e.surface of tissue irradiated by optical spot). Such arrangement may beused for providing improved healing and/or rejuvenation to treatedtissue. Similarly, using more than one optical beam may be used forremoval of color irregularity, ablation of tissue and/or skintightening. The second optical waves with different wavelength mayprovide healing effect.

Methods of treatment may also include application of a negative pressurebefore, during and/or after treatment by the energy. An exemplaryhandheld applicator capable of providing negative pressure is shown inFIG. 27, where the handheld applicator may include one or more cavities213 formed by walls 207. The tissue 212 may be sucked into the cavity213 by negative pressure generated by a source of negative pressure (notshown). Suitable sources of negative pressure include a vacuum pumplocated inside the device and/or external to the device but fluidlyconnected to cavity 213. Negative pressure may create a skin protrusionwhich may move the tissue closer to the lens 210. Negative pressure mayalso provide an analgesic effect. The negative pressure may be in therange of −100 Pa to −2 MPa, −3000 Pa to −400 kPa, or −4000 to −100 kPa.Deflection of the tissue caused by negative pressure may be in the rangeof 0.2 mm to 8mm or 0.5 mm to 60 mm or 1 mm to 50 mm or 1.5 mm to 35 mm.

The negative pressure may be pulsed and/or continuous. Continuouspressure means that the pressure amplitude is continually maintainedafter reaching the desired negative pressure. Pulsed pressure means thatthe pressure amplitude varies, for example according to a predeterminedpattern, during the therapy. Use of Attorney Docket No.206265-0001-P1-US.607019 pulsed pressure may decrease inconveniencerelated to negative pressure by repeating pulses of tissue protrusionsat one treated site, when the energy may be applied. The duration of onepressure pulse may be in the range of 0.1 seconds to 60 seconds, morepreferably in the range of 0.1 seconds to 30 seconds, most preferably inthe range of 0.1 seconds to 20 seconds wherein the pulse duration ismeasured between the beginnings of successive increases or decreases ofnegative pressure values.

Optical treatment may selectively heat the target biological structure.Optical treatment may remove and/or remodel e.g. adipose tissue.Before/after, with some overlap or simultaneously the magnetic treatmentof the target biological structure may induce a muscle contractionwithin the target biological structure to remodel the adipose tissue bynatural adipose tissue catabolism. Adipose tissue catabolism may becaused by apoptosis and/or necrosis of the adipocytes. The musclecontraction caused by induced eddy current may be equivalent to anatural muscle contraction. The adipose tissue may be reduced in naturalway. Additionally, the muscle may be toned and/or shaped in a naturalway. The treatment results may be significantly improved.

Preheating, precooling of the patient's soft tissue (e.g. muscle oradipose cells) by at least one treatment device may be done intemperature range from 25° C. to 60° C. or in range from 32° C. to 50°C. or in range from 36° C. to 45° C.

Heating or cooling of the soft tissue during the treatment may beprovided by any treatment (e.g. RF adipose cells reduction) and may becombined with one or more any others treatment therapies (e.g. cellulitetreatment, massage treatment, rejuvenation by optical waves and/orother).

The temperature of the tissue may be in the range of 30° C. to 105° C.,more preferably in the range of 32° C. to 70° C., even more preferablyin the range of 34° C. and 55° C., most preferably in the range of 35°C. and 44.5° C. Optionally, the temperature of the tissue may beincreased in the range 40.5° C. and 43.5° C.

A cooling/heating mechanism may be used. In some embodiments air may beblown on the patient skin and/or sucked from the patient skin and/or ona protecting layer in order to control surface temperature, create atemperature gradient in the patient soft tissue, cool treatment energysources (e.g. RF electrodes), cool the patient surface, do micro lymphdrainage, remove moisture and/or make the treatment more comfortable. Acooling/heating function may be also provided by flow of a liquid, bythermal diffusion provided through solid, liquid, gel, gaseous materialwith good thermal conductivity and/or by thermoelectric method based onthe Peltier effect.

Optical treatment may be applied before the magnetic treatment. Theeffect of the optical treatment may be stimulating, e.g. increasing thetemperature of the target biological structure to prepare a targetbiological structure to be treated by magnetic treatment inducing atleast muscle contraction. To enhance the efficiency of the treatment insome indications, it may be advantageous to preheat the tissue byinfrared radiation prior to magnetic treatment or combined magnetic andoptical treatment.

The optical waves may be applied to the treated biological structuresuch as a muscle or adipose cells for at least 1 minute, more preferablyat least 5 minutes, even more preferably at least 15 minutes, mostpreferably at least 30 minutes or up to 120 minutes. The optical wavesmay be applied the treated biological structure in pulsed mode and/or incontinually. The optical waves may raise a temperature of the treatedbiological structure. The optical waves may liquefy adipose cells.

Alternatively the effect caused by optical treatment may increase thetemperature of the target biological structure, e.g. adipose cell orfibrous septae. It may be contributed by magnetic treatment causing atleast muscle contraction. The at least muscle contraction may provide amassage effect for biological structures within proximity of the targetbiological structure, improve the blood and/or lymph circulation toimprove local metabolism. Additionally the at least muscle contractionmay reduce the number and/or volume of the adipose cells by energy usedfor the at least muscle contraction itself. Moreover, homogenoustemperature distribution may be provided due to improved blood flow.Alternatively the at least muscle contraction may provide massage effectfor promoting movement of fibrous septae.

The time-varying magnetic field may be applied to the treated biologicalstructure with a repetition rate of at least 1 Hz, more preferably therepetition rate may be in a range of 0.1 to 700 Hz, even more preferablyin the range of 0.5 to 200 Hz, or the range of 1 to 200 Hz, mostpreferably in the range of 1 to 80 Hz.

Simultaneous application of combined magnetic and optical treatment mayreach more significant results than separate use of these treatments.

Simultaneous application of magnetic treatment and optical treatment maybe administered in two modes: a first mode may generate the magneticpulses while optical treatment is active or second mode may generatemagnetic pulses while the optical treatment is not in an activetreatment period, i.e. the period of magnetic treatment and opticaltreatment alternates.

The simultaneous application of magnetic treatment and optical treatmentto the target biological structure may increase the peak magneticcomponent of the entire treatment resulting in improved heating of thetarget biological structure containing higher water volume, e.g. skin.Alternatively, the level of polarization of the optical radiation may beincreased due to magnetic field, or a plane of polarization may rotate,e.g. Faraday's effect may occur. Due to increased temperature of skin,the production and/or remodeling of collagen and/or elastin fibers maybe improved and the skin may be provided with a younger, smoother andenhanced appearance. The effect of overheating the muscle is reduced bythe improved blood flow.

Optical treatment may also be used to attenuate the pain. Alternativelythe repetition rate of the magnetic treatment may attenuate pain aswell.

The optical waves may be generated by high power lasers. The opticalwaves may be applied to the treated biological structure. The timevarying magnetic field may be applied to the treated biologicalstructure as well. A repetition rate of the time-varying magnetic fieldmay be at least 80 Hz, more preferably at least 100 Hz, most preferablyat least 120 Hz. The repetition rate may be in a range of 100 to 250 Hz,more preferably in the range of 120 to 200 Hz, most preferably in therange of 140 to 185 Hz.

Alternatively the repetition rate of the time-varying magnetic field maybe up to 80 Hz in order to improve adipose cells reduction as taughtabove.

The optical waves and the time-varying magnetic field may besimultaneously applied for at least 1 minute, more preferably at least55 minutes, even more preferably at least 30 minutes, most preferably atleast 60 minutes or up to 240 minutes.

Optical treatment may be applied after the magnetic treatment to providecontributing effect such as analgesic effect or it may further improvelocal metabolism. The magnetic treatment may induce at least musclecontraction or to stimulate a muscle structure to increase a musculartonus of the target biological structure. Both effects may provide amassage effect for biological structures within the proximity of thetarget biological structure hence the blood and/or lymph circulation maybe improved to promote local metabolism. The temperature may be locallyincreased by the improved blood flow and the target biological structuremay accept the following optical treatment at significantly higherefficiency. Hence the muscle may be heated at higher quality.Additionally, the collagen and/or elastin fibers may be remodeled orrestored and/or its neogenesis may be improved to provide a younger,smoother and enhanced skin appearance.

Additionally, previous application of magnetic treatment may improveacceptability of the optical treatment. The magnetic treatment mayprovide pain relieving effect for the biological structure hence thethermic effect caused by the optical treatment may be more tolerable forthe patient.

Another benefit may be releasing the adipose cells from the muscle by atleast muscle contraction and/or by temperature increase causing improvedmetabolism of adipose cells. Still another benefit of the at leastmuscle contraction may be mechanic breaking large adipose cells bulksinto smaller bulks which may be easier removed by the lymphatic and/orblood flow. The liquidity of the smaller adipose bulks may becontributed by application of optical treatment. Due to improvedliquidity, improved metabolism and/or blood circulation the cellulitemay be treated in a short time and the visual effect on skin appearancemay be significantly enhanced.

The treatment parameters of the magnetic field may vary as taught above.The treatment parameters may be e.g. repetition rate or magnetic fluxdensity. The time duration may vary as well.

Optical waves may be also applied to attenuate the pain after themagnetic treatment.

The optical waves may be applied to the treated biological structuresuch as a muscle or adipose cells for at least 1 minute, more preferablyat least 5 minutes, even more preferably at least 15 minutes, mostpreferably at least 30 minutes or up to 120 minutes. The optical wavesmay be applied the treated biological structure in pulsed mode and/or incontinually. The optical waves may raise a temperature of the treatedbiological structure. The optical waves may liquefy adipose cells.

Combined treatments may be applied to one target biological structure toprovide combined effect of magnetic and optical treatment. Alternativelythe treatment may be applied to different target biological structures,e.g. optical treatment may be applied to at least adipose cell andmagnetic treatment may be applied to at least one muscle fiber toimprove local and/or adipose cell metabolism.

All applications of combined magnetic and optical treatment may amplifythe resulting effect of the treatment. Therefore the results areachieved in significantly shorter time than the same results achieved byseparate applications of the optical and magnet treatments. Thetreatment may be provided in various predefined treatment protocolsfocused on specific patient's needs, e.g. cellulite treatment,incontinence treatment, pain relieving etc. Each treatment parameter maybe adjusted in the treatment protocol by the operator following thepatient's needs. Alternatively the specific treatment may be designed bythe operator for providing the most effective treatment following thepatient's needs.

All the recited methods may be applied to a patient in a non-invasiveand/or contactless way. Therefore the present methods provide aneffective alternative approach of enhancing the visual appearance withno need of invasive treatment or surgery. Furthermore, the visualresults are appreciable after several treatments. Additionally, theresults include not only the visual appearance enhancement but even theimprovement of the muscle structures hence the patient may feel firmerand tighter. The muscle structures may become toned with no need of anydiet or spending time by exercising in fitness.

All the recited methods may be combined together and may be provided invarious sequences to treat various issues during one treatment.Furthermore each application may induce a plurality of treatment effect,e.g. adipose cell reduction and/or reduction of cellulite.

The optical waves generating device may be placed in a distance up to500 mm from the skin of the patient mm. Particularly in a range of 0.01to 150 mm, more preferably in the range of 0.1 to 100 mm, even morepreferably 1 to 50 mm, most preferably in the range of 2 to 25 mm.

The scanning unit may move over the tissue and stop in one or morepredefined and/or random positions. Duration of the treatment may be inthe range of 1 s to 90 min, more preferably in the range of 10 s to 75min, even more preferably in the range of 30 s to 60 min, mostpreferably in the range of 1 to 30 minutes. The distance of the scanningunit from the tissue may be in the range of 0.5 cm to 100 cm, 1 cm to 80cm or 3 cm to 65 cm. Scanning speed, defined as time change of distanceof two focal point, may be in the range of 0.01 cm/s to 150 cm/s, morepreferably in the range of 0.05 cm/s to 100 cm/s, most preferably in therange of 0.1 cm/s to 80 cm/s.

Applied optical waves may be electromagnetic waves, e.g. UV radiation,light, IR radiation, radiofrequency waves and/or microwave waves.Optical waves may be coherent, non-coherent, depolarized, polarized,monochromatic or polychromatic. The wavelength of the optical waves maybe in the range of 200 nm to 15000 nm, more preferably in the range of250 nm to 10000 nm, even more preferably in the range of 300 nm to 5000nm, most preferably in the range of 400 nm to 3000 nm. The optical wavesmay be combined with the magnetic treatment, i.e. the optical and themagnetic field may be applied to the patient.

Optical waves may be also applied in the narrower spectral band. Some ofthe spectral bands may represent different colors of the visible part ofthe electromagnetic spectrum. The wavelength of the applied opticalwaves may be close to 254 nm, 405 nm, 450 nm, 532 nm, 560 nm, 575 nm,635 nm, 660 nm, 685 nm, 808 nm, 830 nm, 880 nm, 915 nm, 970 nm, 980 nm,1060 nm, 1064 nm, 1320 nm, 1440 nm and/or 1470 nm. Term “close to”refers to deviation of 20%, more preferably 15%, most preferably 10%from the nominal wavelength. Optical waves in the range of 620 to 750 nmmay be beneficial for local circulation enhancement and restoration ofconnective tissue. Optical waves in the range of 400 to 500 nm mayprovide bactericidal effect; optical waves in the range of 560 to 600 nmmay stimulate tissue rejuvenation. Wavelength may be changed duringtreatment. Method of treatment may include application aiming beam ofany visible (e.g. red, blue, green or violet) color, i.e. specificwavelength and/or spectra.

Optical waves may be applied in one or more beams. One beam may includeoptical waves of more than one wavelength, e.g. when the optical wavesare provided by more sources of different intensity. One beam mayprovide an optical spot having an optical spot size defined as a surfaceof tissue irradiated by one optical beam. One optical waves generatingdevice may provide one or more optical spots e.g. by splitting one beamto plurality of beams. The optical spot size may be in the range of0.001 cm² to 600 cm², more preferably in the range of 0.005 cm² to 300cm², most preferably in the range of 0.01 cm² to 100 cm². Optical spotsof different and/or same wavelength may be overlaid or may be separated.Optical spots may be separated by at least 1% of their diameter; opticalspots may closely follow each other and/or be separated by a gap rangingfrom 0.1 cm to 20 cm. Optical spot may have any shape, e.g. circularshape. In case of application of more than one optical beams, thecontroller may control the treatment parameters of every optical beamsindependently.

Optical waves output may be up to 300, 250, 150 or 100 W. Optical wavesmay be applied in continuous manner or in pulses. Pulse frequency may bein the range of 0.2 Hz to 100 kHz, more preferably in the range of 0.25Hz μs to 40 kHz, most preferably in the range of 0.4 Hz to 25 kHz. Thepulse width may be in the range of 0.1 μs to 10 s, more preferably inthe range of 25 μs to 5 s, even more preferably in the range of 50 μs to2.5 s, most preferably in the range of 100 μs to 1000 ms. Pauses betweentwo pulses may last 50 μs to 1 s, more preferably in a range of 1 ms to1s , most preferably in the range of 1 ms to 45 ms.

Pulse energy of the optical waves may be in the range of 0.1 mJ to 100mJ, more preferably in the range of 0.5 mJ to 75 mJ, most preferably inthe range of 1 mJ to 50 mJ. Energy density of the optical waves beam maybe in the range of 0.1 J/cm² to 3000 J/cm², more preferably in the rangeof 1 J/cm² to 1500 J/cm², most preferably in the range of 5 J/cm² to1000 J/cm².

The energy flux density of optical waves during the pulsed mode may bein range between 0.05 mW/mm2 to 13 W/mm2, more preferably in the rangeof 0.05 mW/mm2 to 6 W/mm2, even more preferably in the range of 0.05mW/mm2 to 2 W/mm2, most preferably in the range of 0.05 mW/mm2 to 0.6W/mm2.

Applied optical waves may be high level light. In this case, the outputof the optical waves generating device may be in the range of 0.1 to 300W, more preferably in the range of 0.2 to 75 W, even more preferably inthe range of 0.35 W to 60 W, most preferably in the range of 0.5 to 50W.

Energy flux density provided by optical waves in pulse mode may be inthe range of 0.005 W/cm² to 75 W/cm², more preferably in the range of0.01 W/cm² to 60 W/cm² and most preferably in the range of 0.01 W/cm² to50 W/cm².

The energy flux density of optical waves during the continual mode maybe in range between 0.05 mW/mm2 to 1.2 W/mm2, more preferably in therange of 0.05 mW/mm2 to 0.63 W/mm2, even more preferably in the range of0.05 mW/mm2 to 0.4 W/mm2, most preferably in the range of 0.05 mW/mm2 to0.2 W/mm2.

The magnetic treatment may be combined with mechanical treatment such asapplication of mechanical waves and/or a pressure. The target biologicalstructures may be treated by the mechanical treatment and/or by themagnetic field simultaneously, alternating and/or in overlap. Theapplication of mechanical waves may e.g. positively influence ametabolism of adipose cells, alternatively massage effect may beprovided by the mechanical treatment.

The positive and/or negative pressure may be applied to the patient topromote at least blood and/or lymph flow. The negative pressure refersto pressure below atmospheric pressure. The positive pressure refers topressure value above atmospheric pressure. Atmospheric pressure ispressure of the air in a room during the treatment. The pressure may beprovided by a vacuum, a fluid flow or by a pressure changing element(e.g. a massaging element or pressure cells).

The mechanical treatment may cause synergic effects in combination withthe treatment by the magnetic field. Hence the combined treatment mayprovide improved effectivity of the treatment and/or reduced treatmenttime. Further the visual results are achieved in shorter time period.

FIGS. 10a and 10b illustrate an applicator/a device providing thecombined treatment to the body region of the patient 37.

FIG. 10a illustrates a treatment device 38 including a connection topower source, a magnetic field generating device 39 and mechanical wavesand/or pressure generating device 40.

Alternatively the treatment device may include at least one devicegenerating both, the magnetic field and the mechanical wave and/orpressure. Such a device may be the magnetic field generating device,e.g. a magnetic field generating device, including a metal orferromagnetic material within proximity of the magnetic field generatingdevice. The generated mechanical wave may be shock wave generated byelectromagnetic principle. Alternatively the mechanical wave may be avibration.

FIG. 10b illustrates alternative treatment applied to the patient 37 bytwo separate treatment devices, i.e. by a device providing magnetictreatment 41 and a device providing mechanical waves and/or pressure 42.

The treatment effect may be enhanced by applying negative pressure tothe skin below the applicator. The negative pressure may be in the rangeof 1 Pa to 50 kPa below the atmospheric pressure, preferably in therange of 0.1 to 25 kPa below the atmospheric pressure, more preferablyin the range of 1 to 15 kPa below the atmospheric pressure, mostpreferably in the range of 3 to 8 kPa below the atmospheric pressure.The skin may be pulled towards the inner surface of the applicator.Hence a contact may be enabled by applying the negative pressure.Further the skin may be stretched and a thickness of the skin maydecrease. Alternatively the blood and/or lymph flow may be promoted.

The treatment effect may be enhanced by application of a positivepressure. The dermal blood flow may also be limited and/or eliminated byapplying a constant static pressure. The pressure greater than systolicblood pressure may be used for temporary pushing the blood out of thedermal and/or subcutaneous veins. Alternatively the pressure applicationmay provide correct contact of the applicator with the patient's skin.

Further the positive pressure may follow a predetermined pattern toprovide a massage effect. A varying pressure may increase the bloodand/or lymph flow. The local metabolism may be promoted. Alternatively aregeneration of the treated body region may be promoted as well.

The pressure may be alternatively applied by an applicator designed tocorrespond to the patient's body shape. The applicator may include atleast one pressure applying element, more preferably a plurality ofpressure applying elements may be used. An exemplary device may be e.g.a massage roller. A movement of the roller may follow a predeterminedtrajectory.

Alternatively the positive pressure may be applied by a flexibleapplicator which may be shaped to fit the patient's body, e.g. in ashape of a compression bag, a sleeve, trousers, shorts, a shirt, ajacket or other garment. The device may treat one or multiple bodyparts. The patient's body part such as a limb may not be entirely withinor under the applicator. The plurality of body parts may be treatedsimultaneously.

One or more applicators may treat the body part individually and/or maybe interconnected and may cooperate. Massage units may be designed forproviding lymph drainage.

A correct placement of the compression sleeve may be provided byanatomical design of the applicator and/or at least one sensor. Thecorrect placement may be important for improving a flow and/orpropelling the lymph to lymphatic nodes.

The applicator may include at least one pressure changing element, suchas a pressure cell or a rigid member, providing a massage to thepatient. The at least one pressure changing element may move withrespect to the patient. The movement may be rotational and/ortranslational. A plurality of pressure changing elements may create apressure gradient.

The applicator may include at least one sensor for providing feedback. Atreatment protocol may be adjusted automatically based on the feedback,semiautomatically and/or manually by the operator. Semiautomatically maybe interpreted in the sense that a control system may provide arecommended adjustment of the treatment protocol which may be confirmedby the operator.

The device may be automatically controlled hence continual monitoring bythe operator is not needed. It may reduce time duration and/or costs ofthe treatment. The operator may supervise more than one treated patient.Self-operated or automated devices may prevent mistakes during thetreatment caused by human factors. Further benefit of the self-operateddevice may be an absence of the need for a skilled operator as whenusing a manual device.

A number of pressure changing elements may be up to 6000, preferably inthe range of 1 to 1000, more preferably in the range of 8 to 80, evenmore preferably in the range of 2 to 40, most preferably in the range of4 to 32.

A size and/or the shape of the pressure changing element may fit to thepatient's body. One pressure changing element may apply the pressure tothe patient's skin in an area of at least 0.1, 1, 10, 100, 1000 cm² orup to 2 m2. In an exemplary application the area may be in the range of1 cm² to 1 m2, more preferably in the range of 10 cm² to 1000 cm², evenmore preferably in the range of 40 cm² to 800 cm², most preferably inthe range of 150 cm² to 600 cm².

At least one pressure changing element may continually change theapplied pressure. Alternatively the pressure may be changed inintervals, e.g. in the range of 5 ms to 10 s, more preferably in therange of 0.1 to 5 s, most preferably in the range of 0.5 to 2 s. Aplurality of pressure changing elements may provide the pressuresimultaneously and/or sequentially, i.e. the pressure changing elementsmay be switched in applying the pressure.

The method may change the positive and/or the negative pressure in time.A pressure change may be linear, exponential, logarithmic or sinusoidal.The pressure applied may be changed. Alternatively the applied pressuremay create a pressure gradient. The pressure gradient may vary withinthe treatment. In preferred application the pressure gradient may propelthe lymph to lymphatic nodes. Alternatively the pressure gradient maypropel the lymph in reverse direction to physiologic lymph flow. Atreatment protocol may influence the treated biological structure and/ora layer of the skin. The treatment protocol may be predefined and/oradjustable by the operator following the patient's needs.

The pressure gradient may arise between at least two pressure changingelements. The pressure gradient may be in the range of 0 to 100%,preferably in the range of 0 to 95%, more preferably in the range of 0to 70%, most preferably in the range of 0 to 50%. In an exemplaryapplication the pressure gradient may be 1%, i.e. the applied pressurebetween current and following pressure value decreases and/or increaseswith the pressure gradient of 1%. In an exemplary application thecurrent pressure value may be 5 kPa and the following pressure value maybe 5.05 kPa if the gradient increases or 4.95 kPa if the gradientdecreases.

Cycles of the treatment, e.g. repeated pulse sequences, treatmentpatterns, repeated parts of the treatment protocols and/or its durationmay vary following the patient's needs. A treatment pattern may be aline or a matrix. The pressure changing element may move in trajectoriesincluding linear, circular and/or curvilinear motion. Alternatively themotion may correspond to the patient's lymphatic system. A motion speedof the pressure changing element may vary. The speed be in the range of0.1 and 50 cm-s-1, more preferably in the range of 1 to 30 cm-s-1, mostpreferably in the range of 5 to 15 cm-s-1.

The method may be applied to different body regions such as arms, legs,buttocks, hips, torso or abdomen. The treated area may be at least 0.1mm2, 1 mm2, 1 cm², 10 cm², 25 cm², 50 cm² or more. The treated area maybe in range 0.1 mm2 to 2 m2, preferably in the range of 1 mm2 to 1 m2,more preferably in the range of 1 cm² to 500 cm², most preferably in therange of 2 cm² to 100 cm².

The applied pressure may be at least 0.1, 0.5, 1, 10, 60, 200 kPa or upto 400 kPa. The applied pressure may be in the range of 10 Pa to 30 kPa,more preferably in the range of 100 Pa to 20 kPa, even more preferablyin the range of 500 Pa to 19 kPa, most preferably in the range of 1 kPato15 kPa.

The patient's skin may deflect by the applied positive pressure appliedof at least 0.1, 0.5, 1, 2, 5, 10, 50, 100 mm or more. In the case ofnegative pressure applied the skin may be deflected oppositely.

The applied pressure may last at least 1 ms, at least 0.5, 1, 5 or 30 s.Alternatively, the pressure may be applied for 1, 5, 10, 20, 30, 45, 60minutes or up to 2 hours. In exemplary applications the pressure may beapplied for a time period in the range of 1 s to 5 min or in the rangeof 2 to 30 s. Values of applied pressure may vary during the cycles.

The following table illustrates exemplary treatment protocols

Recommended Recommended Name pressure range [kPa] time [min]Characteristic and effects of the program Massage  5-11 30 The pressurecells are inflated and deflated in succession. The effect is similar tomanual massage. Physiological 3.5-9.5 30 Contributes a rehabilitation ofthe vascular system. Preparation 3.5-9.5 20 Treatment of body's tissuesbefore further lymphatic treatment. Lymph drainage 3.5-9.5 45 Similar tomanual lymphatic massage. The most suitable program for aestheticmedicine. Elephantiasis 3.5-11  45 The pressure cells are inflated insuccession and remain inflated. Improve lymph flow. Venopress 2.5-7   30The program for increasing blood flow in peripheries. Helps to preventvascular problems. Embrocation 3.5-9.5 45 Sequential inflating of singlepressure cell in order to ensure careful removing of lymphatic fluid.Reversed combi 3.5-9.5 45 Pressure cells are inflated in preset pattern.Successively pushing the lymphatic mass proximally.

The combined treatment using the magnetic field and application ofpressure to the patient may provide a massage effect, improve bloodand/or lymph circulation or provide anti-edematous effect. A removing ofthe adipose cells, local metabolism including the local metabolism ofthe adipose cells, elastogenesis and/or neocollagenesis may beaccelerated. The adipose cells may be reduced by natural catabolism. Dueto improved blood and/or lymph circulation a panniculitis may beprevented. Erythema may also be reduced.

The skin tightening effect may occur. Hence the skin appearance mayobtain younger and smoother appearance.

Further improved regeneration of the treated biological structure suchas a muscle may be promoted hence a muscle fatigue may occur afterlonger time period and the treatment may last longer. Enhanced resultsmay be achieved compared to the treatment by single methods.

The magnetic treatment may be combined with application of mechanicalwaves. One type of mechanical waves may be shock waves and/or acousticwaves which are characterized by steep pressure amplitude growth incomparison to the surrounding pressure. The shock wave is furthercharacterized by non-linearity during the propagation. The positive peakpressure is above 0.1 MPa, more preferably 3 MPa, even more preferablyat least 7 MPa, most preferably at least 15 MPa or up to 150 MPa. Thepulse duration of the shock wave (based on the time the pressure exceedsa half value of peak positive pressure) may be preferably in the rangeof hundreds of nanoseconds to tens of microseconds.

Shock waves may propagate naturally non-focused/radial, planar ormoderately focused. Non-focused/radial, planar shock waves arecharacterized by smooth/soft propagation and therefore these waves arepreferred. A pneumatic principle of generating shock waves may beperformed by pressurized gas vibrating a percussion guide or byballistic shock waves which may be generated by striking of a bulletinside a guiding tube to a percussion guide. The bullet may beaccelerated by pressurized gas, electric field, magnetic field, springor other technique.

Shock waves may differ from ultrasound waves. The difference may be inwaveform and/or in its propagation. Significant differences may also bein physical effect of ultrasound and shock waves on the treated tissue,particularly a cavitation effect. Shock waves may reduce the cavitationand the violent break up of cells resulting from the cavitation.

The treatment method may use the magnetic treatment and the treatment byshock waves enabling improvement of the biological structure such assoft tissue, e.g. a connective tissue in the skin area such as collagen,elastin and/or adipose cells in epidermis, dermis, hypodermis and/or inperitoneal cavity. The structures below the skin such as a muscle mayremain untreated and/or unharmed. Alternatively the treatment may alsocreate micro-disruptions of the treated tissue, create a movement,rotation or polarization of particles by the magnetic field. Theimprovement of the connective tissue may be promoted by collagen and/orelastin generation and/or remodeling. Alternatively the adipose cellsmay be reduced.

The combined treatment may result in increased cell membranepermeability, which may result in increased liquefying of adipose cellsor lipolysis. Combination of both treatment methods may highly reduce arisk of adipose cells inflammation.

The combined treatment may improve lymph and/or blood flow. Further thetreatment by shock waves may provide a pain relief and/or myorelaxationeffect. Similar effects may also be provided by the treatment methodsusing the magnetic field hence the effect may be provided by twodifferent synergic treatments. The results achieved by combinedtreatment are more significant than results achieved by single methodapplication.

The shock waves may be applied to the patient prior, during and/or afterapplying the magnetic field to the patient.

The shock waves applied prior the application of magnetic field maymechanically disrupt larger clusters of adipose cells to smallerclusters which may be better treated by the magnetic field.

Treatment may be applied to the patient, particularly to the body regionincluding calf, thighs, saddlebags, buttocks, abdomen, love handles, brafat region, arms, face, neck, breasts, shoulders and/or thorax. Thepresent method may be used for treatment of sexual issues such aserectile dysfunction. Treatment may be targeted to the cavities of thebody, e.g. mouth, vagina or anus.

The applicator may be moved along the lymphatic vessels. The treatmentmay increase the velocity of lymph flow in lymph vessels. Propermovement of the applicator may be performed by the operator via director indirect control and/or by a robotic system. The applicator may bemoved in continuous longitudinal movements. Alternatively the movementmay be of any shape e.g. a loop, circular and/or random. The applicatormay also be moved in straight line. The movement of the applicator maybe in a direction from the center of the treated body part to itsperiphery. Movement of the applicator may also be in the direction fromthe periphery of the treated body part towards the body. Continuousmovement may be directed to one or more lymph nodes e.g. lymph nodes inthe groins. Exemplary treatments may be found in U.S. Patent ApplicationNo. 15/471,946.

A repetition rate of the shock waves may be in the range of 0.1 to 100Hz, more preferably in the range of 0.5 to 50 Hz, most preferably in therange of 1 to 40 Hz.

An energy flux density of the shock wave may be in the range of 0.001and 160 mW·mm-2, more preferably in the range of 0.001 to 100 mW·mm-2,most preferably in the range of 0.001 to 50 mW·mm−2.

Methods may include a direct contact of the applicator with the tissuewhich may result in a deflection of the tissue by the applicator. Thedeflection may be in the range of 0.01 to 30 mm, 0.02 to 20 mm or 0.05to 10 mm.

A surface of an energy delivery element providing shock waves may be atleast 0.01 cm², preferably in the range of 0.05 to 50 cm², morepreferably in the range of 0.75 to 40 cm², most preferably in the rangeof 0.1 to 35 cm².

The direct contact of the applicator with the tissue may form a recessin the tissue during the treatment. The recess may be in the range of0.01 to 80 mm, 0.1 to 60 mm, 0.5 to 40 mm or 0.1 to 35 mm.

The magnetic field and shock waves may be applied with a ratio which mayprovide significant results, optimal treatment and minimal adverseeffects. The ratio between the repetition rate of the magnetic field andthe frequency of shock waves (Hz/Hz) may be in the range of 0.001 to 50,more preferably in the range of 0.02 to 30, most preferably in the rangeof 0.06 to 15.

Another type of mechanical waves may be ultrasound waves. Ultrasoundwaves are characterized by periodic pressure oscillation duringpropagation and possible cavitation effect within the target biologicalstructure, e.g. in adipose tissue.

A cavitation is a formation of gas bubbles in a fluid environment whichoccurs during a negative pressure wave in a liquid. Ultrasoniccavitation bubbles represent acoustic inhomogeneity in which incomingacoustic energy is absorbed and dissipated. Due to high frequency of theultrasound waves, the acoustic energy may cause rapid growth ofcavitation bubbles and cavitation effects, with breakup of the bubblesand violent damage of the surrounding tissue, e.g. adipose cells.

A rate of generating such microdamages may be in the range of 1 to 1 000per second, preferably in the range 5 to 800 per second, even morepreferably in the range 10 to 750 per second, most preferably in therange of 50 to 500 or up to 10 000 per second. Alternatively the rate ofgeneration the microdamages may be higher.

The ultrasound waves may be focused, unfocused or weakly focused.

Generally, the ultrasound waves are generated in a frequency range from100 kHz to 100 MHz, preferably in the range of 1 to 20 MHz, morepreferably in the range of 2 to 12 MHz, even more preferably in therange of 3 to 10 MHz, most preferably in the range of 4 to 7 MHz. Thefrequency of the generated ultrasound waves may vary depending on anapplication, a depth of penetration and/or a target biologicalstructure.

Ultrasound waves of power density up to 1 W/cm² and frequency in therange of 1 to 20 MHz may be used for medical imaging. Imaging ultrasoundwaves may be used for targeting the target biological structure whichmay be treated. Imaging ultrasound waves avoid heating and/or thecavitation effect due to low power density.

A power of the treatment ultrasound waves used for the present methodmay be in the range of 0.1 to 200 W, preferably in the range of 0.5 to100 W, more preferably, even more in the range of 1 to 50 W, mostpreferably in the range of 2 to 20 W, or up to 10 kW.

A power density of the ultrasound waves may be in the range of 0.1 W/cm²to 1 kW/cm², more preferably in the range of 10 to 500 W/cm², mostpreferably in the range of 20 to 100 W/cm².

Energy applied to the target biological structure may be 0.1, 1, 10, 50,100, 500 J or more. An exemplary applied energy may be in the range of0.1 J to 1 kJ, preferably in the range of 1 to 500 J, more preferably inthe range of 5 to 250 J, most preferably in the range of 10 to 100 J.

A frequency of the ultrasound waves used for an aesthetic treatment maybe in the range of at least 100 kHz, e.g. in the range of 0.5 to 100MHz, preferably in the range of 1 to 50 MHz, more preferably in therange of 2 to 30 MHz, even more preferably in the range of 3 to 20 MHz,most preferably in the range of 5 to 15 MHz. The frequency may varywithin one treatment. A plurality of ultrasound waves of differentfrequency may be applied to achieve different treatment effects such asablation, coagulation, cavitation or non-thermal effect.

The ultrasound waves may be applied in pulses. Time duration of thepulses may be in the range of 1 μs to 60 s, more preferably in the rangeof 1 to 5000 ms, even more preferably in the range of 5 to 750 ms, mostpreferably in the range of 50 to 500 ms. Alternatively the ultrasoundwaves may be applied continuously.

A repetition rate of the pulses may be at least 0.1, 5, 10, 25, 50, 100Hz, or more. The high repetition rate of the pulses in order of kHz mayalso be used, e.g. 1 or 5 kHz.

Further, ultrasound waves may generate heat within the target biologicalstructure, e.g. adipose cells. A temperature of the target biologicalstructure may be e.g. in the range of 37 to 60° C. or in the range of 43to 48° C. Apoptosis of the adipose cells may be induced. The treatmentdevice may include a temperature sensor for adjusting the power of theultrasound waves to maintain the target biological structure withinoptimal temperature range.

The treatment may last at least 5 seconds, preferably at least 1, 5, 10,20, 30, 60 minutes or up to 240 minutes.

An applicator may be moveable. A motion of the applicator may follow apredetermined trajectory, e.g. scanning motion may be used.Alternatively zig-zag, curvilinear or circular motion may be used.

The treatment device may calculate a correct speed of the motion.Further the speed of the motion may be monitored by at least one sensorand the treatment device may provide information to the operator. Ahuman machine interface may notify the operator in a human perceptibleform that the speed of the motion is incorrect. A notification may bevisual, e.g. flashing light or light change; audible such as beep; ormechanically perceptible form such as vibration of the applicator. Thespeed may be adjusted following the patient's needs.

Following the speed of the motion the pulses may be spaced apart indistances in the range of 0.01 to 25 mm, more preferably in the range of0.1 to 10 mm, even more preferably in the range of 0.5 to 5 mm, mostpreferably in the range of 1 to 3 mm.

The target biological structure such as adipose cells in a fat layer maybe targeted by imaging ultrasound. The imaging ultrasound may be usedfor adjusting the frequency, focus and/or energy of the treatmentultrasound. The ultrasound energy may be delivered to the targetbiological structure where the cavitation effect or heat may begenerated.

A specific depth of the fat layer may be treated due to specificpenetration depth and/or the focus which may be adjusted by theoperator. The specific depth may be at least 1, 5, 10, 25, 50, 100, 150mm or more. Exemplary depth may be in the range of 0 to 150 mm, morepreferably in the range of 1 to 100 mm, even more preferably in therange of 5 to 50, most preferably in the range of 5 to 30 mm.

Alternatively the treatment method may be applied to shallow layers ofthe skin such as in the depth up to several millimeters, e.g. in therange of 0.01 to 20 mm, more preferably in the range of 0.1 to 10 mm,even more preferably in the range of 0.2 to 5 mm, most preferably in therange of 0.75 to 3 mm.

An ultrasound waves generating element may be coupled to the patient'sskin. Alternatively the ultrasound waves generating element may be inthe applicator in mechanical waves transmitting medium, e.g. a fluidsuch as water or oil, alternatively rigid transmitting medium may beused. The ultrasound waves transmission from the applicator to thepatient may be enabled by ultrasound gel.

The treatment method may be used for reducing adipose cells in numberand/or in volume, further the method may reduce cellulite appearance.The treatment may cause lipolysis, preferably apoptosis of the adiposecells. Adipose cell metabolism may also be increased. Further bloodand/or lymph flow or local metabolism may increase.

The treatment by ultrasound waves may be preferably combined withanother mechanical treatment which may provide physical damage of largeadipose cells cluster to smaller clusters to provide enhanced results.Further the combined mechanical treatment method may move and/or stretchthe fibrous septae hence the cellulite appearance may also be reduced.

Alternatively the method may be used for enhancing a visual appearanceof a skin. Enhancing the visual appearance of the skin may beinterpreted as an increase of skin elasticity or collagen and/or elastinproduction; reduction of adipose cells in number and/or volume, scars,stretch marks, wrinkles or circumferential reduction. Enhancing thevisual appearance of the skin may result in skin rejuvenation or skintightening effect, skin laxity may also be reduced.

The treatment may be applied to the face of the patient. The skincompartments, e.g. elastic fibers such as collagen or elastin may beremodeled and/or a new production of the elastic fibers may be promoted.Non-invasive treatment method reduces downtime for recovery comparing tocurrently used invasive methods. Further the method may be comfortablefor the patient.

In general the mechanical treatment may be applied prior, during orafter the treatment by magnetic field. The blood and/or lymph flow maybe increased, metabolism may be improved. Further collagen and/orelastin production may increase.

Shock, acoustic and/or ultrasound waves may break large clusters ofadipose cells into smaller clusters which may be better metabolized. Theshock wave may also provide a relaxation effect for the treated bodyregion hence the treated body region may be prepared for the followingmagnetic treatment.

Alternatively shock waves may be applied after the magnetic treatment topromote lipolysis and/or adipose cells apoptosis influencing ER stresswhich may result from the applied magnetic field prior the shock wavesapplication.

Alternatively the positive and/or negative pressure application mayprepare a metabolism for the treatment by magnetic field.

The ultrasound waves applied prior the magnetic field may cause damagesto adipose cells, e.g. a disruption. Further the ultrasound waves mayheat the adipose cell and/or liquefy the adipose tissue. The adiposecells may be metabolized at higher quality by the following magnetictreatment promoting local metabolism, blood and/or lymph flow. Furtherthe applied magnetic field may promote a lipolysis by the musclecontraction.

Exemplary application of a combined treatment may be application ofultrasound waves for damaging the adipose cells followed by the magnetictreatment. The shock waves may be subsequently applied to promote alymph circulation and/or enhance metabolism of the treated adiposecells.

Another exemplary application may be application of positive and/ornegative pressure simultaneously with the magnetic field. The localmetabolism, blood and/or lymph flow may be improved as well. Furtherskin tightening effect may be achieved.

The time-varying magnetic field may treat biological structures belowthe skin such as a muscle. Induced muscle contraction may move the skinlayer. On the other hand, the mechanical treatment may influence theskin, the layers below the skin may be less influenced due todissipation of the pressure within the skin layers. Combination of themechanical treatment and the magnetic treatment may provide a complextreatment method enhancing visual appearance of the patient's body by,e.g. reducing adipose cells or cellulite appearance; providing smootherskin and/or increasing skin elasticity or shaping the muscle. Thecombined treatment may achieve the treatment effect in significantlyshorter time periods compared to single treatment methods.

The magnetic field may be combined with application of heat and/or cold.The body region may be heated/cooled. The target biological structuresmay be selectively treated due to different tolerance of variousbiological structures to heating/cooling. Applying of heat/cold mayimprove metabolism of the biological structure, alternatively areduction of the biological structure may occur.

The magnetic treatment may be combined with optical treatment. Theoptical treatment may be used for remodeling, reducing the volume and/ornumber of adipose cells, body contouring or tightening skin, skinrejuvenation, wrinkles and/or stretch mark reduction, mole mark removal,tattoo removal, enhanced skin tightening, hair removal, treatment ofvascular lesions, acne treatment, sweating reduction and otherappearance improving and/or pain relief treatment without contacting theskin. The treatment may optionally be performed simultaneously orconsecutively during the same session.

Optical treatment may selectively heat the target biological structure.Optical treatment may remove and/or remodel e.g. adipose tissue.Before/after, with some overlap or simultaneously the magnetic treatmentof the target biological structure may induce a muscle contractionwithin the target biological structure to remodel the adipose tissue bynatural adipose tissue catabolism. Adipose tissue catabolism may becaused by apoptosis and/or necrosis of the adipocytes. The musclecontraction caused by induced eddy current may be equivalent to anatural muscle contraction. The adipose tissue may be reduced in naturalway. Additionally, the muscle may be toned and/or shaped in a naturalway. The treatment results may be significantly improved.

Combined applications of optical waves and magnetic field may be used.The optical treatment may include treatment by optical waves. The magnettreatment may be provided by permanent magnets, electromagnetic devicesgenerating a static magnetic field or preferably by magnetic devicesgenerating time-varying magnetic field. In the preferred application themethod may combine treatment by a pulsed magnetic field and opticaltreatment. The application is not limited by the recited combination sothe combined method may include magnetic treatment and any treatment byelectromagnetic field such as radiofrequency waves, e.g. microwaves,short waves or long waves.

Various biological structures have a different tolerance toheating/cooling. Hence target biological structures may be remodeled,e.g. adipose cells may be selectively reduced. The cells different fromadipose cells such as epidermal cells, are not reduced by theheating/cooling. The selective reduction of adipose cell may be causedby e.g. crystallization within adipose cells. The heating/cooling of theadipose cell may reduce the number and/or volume of adipose cells bylipolysis, apoptosis and/or necrosis.

Although the following exemplary treatment describes applying cold tothe patient, the treatment method is not limited to the exemplaryapplication. The method may include heating the patient instead ofcooling the patient.

The cooling may be provided in a contact, indirect contact and/ornon-contact manner. Contact cooling may be provided by a cooling elementplaced to the proximity of the treated body region, e.g. a thermallyconductive material such as metal, gel or ice may be used. Indirectcontact may be provided by a flow of cooling media within a layer offlexible and/or rigid material, e.g. cooling media such as glycerol,saline or water solution may be used. The cooling element may include aplurality of passages which the cooling media may flow in. Non-contactcooling may be provided by radiant cooling. Alternatively cooling mediamay be applied directly on the body region. The cooling media used fornon-contact heating/cooling may be preferably a fluid, e.g. a gas orliquid. The gas may be applied in form of a spray, e.g. cold air, CO2 orN2 may be used. The cooling media may be at a predetermined temperaturewhich may be controlled by the device to induce selective treatment ofthe target biological structure.

In an exemplary application the adipose cells may be selectively treatedby cooling. A cooling media may be applied to the body region. Areduction of adipose cell may be induced by cooling the adipose cell.The cells different from adipose cells are not reduced by the cooling.

The temperature of the cooling media and/or element may be less than thetemperature of the patient's body. The temperature of cooling media maybe at least −196° C. The temperature of the cooling element may bepreferably in the range of 40 to −40° C., more preferably in the rangeof 20 to −20° C., even more preferably in the range of 10 to −15° C. orin the range of 5 to −10° C. A temperature of the adipose cells may beabove a freezing point of water to prevent a reduction of cellsincluding water. The temperature of the adipose cells may be preferablyin the range of 37 to −10° C., more preferably in the range of 20 to −4°C., even more preferably in the range of 15 to −2° C. or around 4° C.The temperature of epidermis may be at least −40, −20, −10, 15, 20, 35°C., more preferably the temperature of epidermis may be in the range ofaround 5 to −5° C. The term around may be interpreted to mean in therange of 10% of the particular value.

The temperature of adipose cells may vary during the treatment. Thetemperature of the adipose cells may oscillate around a predeterminedtemperature. The temperature of the adipose cells may also follow atemperature profile in a predefined temperature range. The temperatureand/or the temperature range may be adjusted following the patient'sneeds.

Alternatively the adipose cells may be heated prior, during and/or aftercooling. The term “heat prior” refers to preheating the adipose cellsbefore cooling treatment. The term “heat during” refers to cyclicallychanging periods of cooling and heating the adipose cells during thetreatment. The treatment may also include passive periods betweenheating and/or cooling. The term “passive period” refers to applyingneither heating nor cooling. The term “heat after” refers to applyingheat after the cooling treatment. The periods of heating/cooling and/orpassive periods may be adjusted following by the patient's need.

The cooling may be applied for at least 10 seconds. Time duration ofcooling the body region may be in the range of 1 to 240 minutes, morepreferably in the range of 5 to 120 minutes, even more preferably 10 to60 minutes, most preferably up to 30 minutes.

The cooling element and/or media may be applied continuously and/or inpulses. Continuous application may be used for a cooling element and/ormedia at a temperature above 0° C. Pulsed mode may be used forapplication of fluids below 0° C. The cooling may be provided cyclicallyfor short periods in order of milliseconds, e.g. N2 may be appliedcyclically to prevent damage to epidermis/dermis. The cooling elementand/or media may be applied preferably non-invasively, e.g. by topicalapplication. Alternatively the cooling element and/or media may beapplied subcutaneously, e.g. injected.

The cooling element may correspond with the body region. The coolingelement may be adjustable in shape to fit the body region. The coolingelement may be made of flexible material to be modified in shape tofollow the shape and/or contour of the body region. A fitting of thecooling element may provide homogenous treatment and/or temperaturedistribution. Further the heat exchange may be optimized at thecontacted surface.

A treatment may induce a thermal gradient in the body region, i.e. theshallow layer of the skin such as epidermis and/or dermis may have alower temperature than the deeper layer such as adipose tissue. Theeffect of cooling may be improved by limiting and/or eliminating dermalblood flow. The dermal blood flow may be limited by applyingvasoconstrictive medicine, preferably topically administered.

The dermal blood flow may also be limited and/or eliminated by applyinga pressure. The pressure greater than systolic blood pressure may beused for pushing the blood out of the dermal and/or subcutaneous veins.The deeper adipose cells may be cooled and/or the cooling of the adiposecells to the temperature sufficient to reducing the adipose cells may bereached in shorter time period. Furthermore appropriate contact of thecooling element may be provided by the pressure in case of contacttreatment.

The treatment effect may also be enhanced by applying negative pressureto the skin below the applicator, e.g. a convex cooling element may beused. The skin may be pulled towards the inner surface of the coolingelement. Hence the contact may be enabled by applying negative pressure.Alternatively, the folded tissue may be pinched by two or more coolingelements and the cooling may be applied to the tissue, particularly toadipose cells. Further the skin may be stretched and a thickness of theskin may decrease. Skin thickness decrease may promote improved heattransfer to/from adipose cells.

The cooling may be applied with application mechanical treatment such asacoustic, ultrasound, and/or shockwave treatment to enable morehomogenous treatment effect. The adipose cells reduction may also bepromoted by physical movement of the body region by e.g. massaging, orvibrations. The pressure applied to the body region may vary to improvethe results.

An apoptotic index may increase after cooling the body region. Theapoptotic index refers to a percentage of apoptotic cells in specimen.The apoptotic index may increase due to cooling up to ten times greatervalue compared with the value prior the cooling.

Based on the apoptotic index a treatment combining various methods maybe designed as a tailor-made solution following the patient's need. Thecooling may be applied to the body region of the patient prior, duringand/or after applying a magnetic field to the patient.

A pain relieving medicament may be provided during the treatment if thepatient is more sensitive to decreased temperature. A topicalapplication may be preferred. The pain relief effect may be provided bya magnetic field of repetition rate at least 100 Hz, more preferably 120Hz, even more preferably at least 140 Hz or at least 180 Hz. The painrelieving effect may be provided before, during or after the treatment.

Cooling the body region prior to applying the magnetic field mayinfluence a metabolism of adipose cells. Alternatively, the cooling ofthe adipose cells may induce apoptosis, lipolysis, autophagy and/ordisruption of the adipose cells. A release of FFA from adipose cells mayinduce ER stress as recited above. The application of the magnetic fieldmay cause at least muscle contraction reducing the adipose cells.Furthermore the released FFA from adipose cells influenced by coolingmay be used as energy source for muscle work. Hence the cooling may befollowed by treating a patient by magnetic field inducing at leastmuscle contraction. Due to the combined effect of cooling and magnetictreatment the adipose cells may be reduced in number and/or volume.Moreover the muscles may be shaped, tightened, strengthened and/or thevolume of the muscle may increase. Additionally, the celluliteappearance may be reduced due to muscle work.

The magnetic treatment may provide a massage effect. Hence blood and/orlymph flow may be improved. Additionally frozen tissue may be relaxed.

The combined magnetic treatment may be applied immediately afterconventional non-invasive and/or invasive aesthetic treatment method,more preferably around 0.01 to 24 hours after a conventional treatment,e.g. 1, 2, 8 or 20 hours. The combined treatment may be appliedperiodically. Alternatively, the treatment by conventional non-invasiveand/or invasive aesthetic treatment method and/or magnetic field may beapplied separately, e.g. treatments may alternate in appropriateperiods. The period may last from 12 hours to 1 month, more preferablyfrom 1 day to 2 weeks, most preferably from 3 days to 1 week.

In an exemplary application of the treatment method a patient's bodyregion may be cooled by a cooling element for e.g. at least 20 minutesup to 1 hour. After stopping the cooling the body region may be treatedby magnetic field for e.g. 15 to 45 minutes.

Cooling the body region may be applied simultaneously while the bodyregion is treated by magnetic field within one treatment.

The magnetic cooling may be provided to the patient while the patient isbeing treated by magnetic field.

Alternatively, cooling may alternate with treatment by magnetic field,i.e. the magnetic field is applied when cooling is not provided to thepatient or vice versa. Periods of alternating cooling and magnetictreatment may vary.

The magnetic field may be preferably applied in burst mode. Each burstcontains train of magnetic impulses and a period of no magnetictreatment. The train may include a plurality of magnetic impulses. Anumber of magnetic impulses may vary in the range of at least 1 to 10000impulses, more preferably in the range of at least 10 to 1000 impulses.The time duration of the train and/or the period of no magnetictreatment may vary in order of milliseconds to order of seconds, e.g. inthe range of 100 milliseconds to 100 seconds, more preferably in therange of 1 to 30 seconds, most preferably in the range of 5 to 15seconds.

In one exemplary application the body region may be cooled for a periodof e.g. at least 5 minutes. After stopping the cooling the body regionmay be treated by a magnetic field for a period of e.g. at least 5minutes. After stopping the magnetic treatment the body region may becooled.

The cooling may also be applied after magnetic treatment. The treatmentby magnetic field may provide stimulation, pain relief and/or amyorelaxation effect for the treated body area before cooling. Thecooling applied with pressure may be better accepted by the adiposetissue when the muscle below the adipose cells is relaxed. Alternativelythe magnetic treatment may provide a temporary pain relief effect hencea patient suffering from a lower pain threshold, e.g. cool sensitivity,may be treated.

In an exemplary application the body region may be treated by a magneticfield for a period of e.g. at least 15, 20 or 30 minutes. After stoppingthe magnetic treatment the body region may be cooled.

The cooling may be applied immediately after magnetic treatment, morepreferably around 1 to 24 hours after magnetic treatment, e.g. 1, 2, 8or 20 hours after magnetic treatment. The combined treatment may beapplied periodically.

In an exemplary application of the treatment method a patient's bodyregion may be treated by magnetic field for e.g. at least 20 minutes upto 1 hour. After stopping the magnetic treatment the body region may betreated by cooling for e.g. 15 to 45 minutes.

In the previously described exemplary treatment methods the cooling ofthe patient may be replaced by heating the patient.

FIGS. 11a and 11b illustrate a device/devices providing the combinedtreatment to the body region of the patient 43.

FIG. 11a illustrates a treatment device 44 including a connection topower source, a magnetic field generating device 45 and means forproviding heating/cooling 46, e.g. RF source or cooling element. In analternative embodiment the treatment device may include at least onemagnetic field generating device which is also able to provideradiofrequency waves.

FIG. 11b illustrates alternative treatment applied to the patient 43 bytwo separate treatment devices, i.e. by a device providing magnetictreatment 47 and a device providing heating/cooling 48.

All the recited combined treatment methods may be provided by at leastone applicator. The applicator may provide cooling and magnetictreatment. Alternatively one applicator may provide cooling and secondapplicator may provide magnetic treatment.

The target structure may be treated by combined methods which may beused for remodeling the adipose tissue, body shaping and/or contouring,muscle toning, skin tightening, skin rejuvenation, wrinkle removing,reducing stretchmarks, breast lifting, lip enhancement or treatment ofcellulite in general by application of electromagnetic radiation totarget structure to selectively heat the target tissue to remove and/orremodel adipose tissue from the target tissue. The second approach is totransmit a magnetic treatment to the target structure, inducing at leastmuscle contraction within the target structure to remodel the adiposetissue by natural adipose tissue catabolism. Adipose tissue catabolismmay be caused by apoptosis or necrosis of the adipocytes. The musclecontraction caused by induced eddy current is the same as a naturalcontraction. The adipose tissue may be reduced in natural way.Additionally, the muscle may be shredded in a natural way. Therefore theeffect resulting in body shaping and/or contouring may be significantlyimproved.

The combination of the recited method may improve currently usedapplications in various aspects and the effect of the treatments may besignificantly enhanced. The application of a radiofrequencyelectromagnetic field may be combined with application of a magneticfield applied before, simultaneously or after the radiofrequencytreatment. The application of a magnetic field may induce many benefitsfor radiofrequency treatment, such as applications inducing at leastmuscle contraction, myorelaxation effect or analgesic effect. Theperfusion or metabolism may be improved as well.

The at least muscle contraction may induce enhanced effects on adiposetissue reduction by catabolism of the adipose tissue and burning energyfrom adipose tissue. The total adipose tissue reduction effect may beenhanced by radiofrequency treatment.

Additionally, the at least muscle contraction may improve a blood flowand/or perfusion in the treated body region. The improved blood flow maybe caused by activation of muscle pump and/or by the muscle necessity ofmore oxygen due to the at least partial contraction. The blood flow mayincrease rapidly and it may last temporarily, preferably up to 1 hour,more preferably up to 45 minutes, most preferably up to 30 minutes. Dueto increased blood flow and/or local perfusion, the risk of overheatedmuscle may be limited or even eliminated. Further the homogeneity of thethermal field induced by thermal effect of radiofrequency treatment maybe significantly enhanced and/or the temperatures may bewell-balanced/compensated in the target body region. Still anotherbenefit may be prevention of creation any hot spot caused by steepthermal gradient.

Due to improved blood flow, perfusion and/or lymph flow the metabolismmay be improved. Additionally, the effect of radiofrequency treatmentmay be enhanced by improved metabolism, e.g. cellulite treatment, bodyshaping and/or contouring, skin tightening or skin rejuvenation. Furtherbenefit may be reducing or eliminating the risk of panniculitis or localskin inflammation since any clustering of the treated adipocytes may beprevented by the improved metabolism. The improved blood and/or lymphflow may contribute the removing of the adipocytes. The removing of theadipocytes may be promoted by higher number of cells phagocytosing theadipocytes as well. Synergic effects of magnetic and RF treatment maysignificantly improve metabolism. Therefore the possibility of adverseevent occurrence may be limited and treatment results induced by thepresent invention may be reached in shorter time period.

Further the at least muscle contraction may improve the movement oflymphatic vessel and the lymph flow may be improved.

In the preferred application the RF and/or magnetic field may bemodulated. In the most preferred application both treatments aremodulated. The magnetic treatment may be modulated in the magnetic fluxdensity domain, repetition rate domain, or impulse duration domain, toprovide different treatment effects and to prevent adaptation of thetarget biological structure. The radiofrequency treatment may bemodulated in the frequency domain, intensity domain and/or time domainto reach the most complexity and/or efficiency of the target treatedbiological structure. The modulation in the time domain may be changingthe active and passive periods of treatment, e.g. the radiofrequencytreatment may include period with no stimulation, i.e. theradiofrequency treatment may be not continual but the treatment may beprovided in pulses. The periods of no stimulation may vary and may beadjusted by the operator. Due to modulation during the treatment,different target biological structures may be treated in the differentdepth.

The application may be contact or in the preferred application thetreatment may be applied contactless. Contactless application may avoidall biocompatibility factors which may occur during contact treatment.In the most preferred application the treatment may be provided byself-operated device. Hence the applicator and/or magnetic fieldgenerating device needn't to be guided by the operator. The applicatormay be positioned on the patient in static position or it maydynamically move and provide therapy in predetermined pattern. Thedevice, the applicator and/or the magnetic field generating deviceneedn't to be operated by the operator or needn't be under continualoperator's surveillance for at least 5, 10, 30, 60, 240 seconds orlonger with no risk to the patient. The applicator may be fixed insufficient distance from the patient's skin enabling the safe treatmentfor the patient. Self-operated treatment may be provided by a hand-heldapplicator or the applicator may be fixed to stand-alone device. Theself-operated treatment may be also enabled using various types ofsensors in communication with the device for monitoring the treatmentand/or the patient. The at least one sensor may be e.g. reactive sensor,electrochemical sensor, biosensor, biochemical sensor, temperaturesensor, sorption sensor, pH sensor, voltage sensor, sensor for measuringdistance of applicator from the patient surface and/or from the treatedarea, position sensor, motion detector, photo sensor, camera, sounddetector, current sensor, sensor for measuring of specific human/animaltissue and/or any suitable sensors measuring biological parametersand/or combination thereof such as sensor for measuring dermal tensileforces, sensor for measuring the activity of the muscle, musclecontraction forces, tissue impedance or skin elasticity.

Further the homogeneity of the treatment may be improved by severalapproaches. A first approach may be represented by a moveable applicatorproviding the dynamic treatment to a large target area. The dynamictreatment may improve the homogeneity of applied treatment energy andadditionally due to large area the effect is uniform and/or wellbalanced. Static positioning of the applicator may be used as well.Another approach of improving homogeneity may be represented by using abolus. The bolus may provide improved transmittance of theelectromagnetic energy to the treated biological structures.Additionally, the bolus may prevent occurrence of hot spots within thetreated area; the bolus may provide constant temperature to the targettreated surface area; or the bolus may increase the homogeneity of theradiofrequency waves application by providing a homogenous medium forelectromagnetic waves propagation not being influenced by the interfaceof the target treated area and an air. The bolus may profile theelectromagnetic field to enhance the effect of the treatment. In stillanother approach an air gap may be between the applicator and thepatient.

The treatment by magnetic and/or electromagnetic field may be incontinuous or discrete mode. In one application the magnetic treatmentmay be applied in continual mode with no pauses and the electromagnetictreatment may be applied in pulsed mode to provide improved adiposetissue reduction caused by natural process and by the increasedtemperature. In another application the electromagnetic treatment may beapplied continuously with no pauses and the magnetic treatment may beapplied in pulsed mode to provide improved thermal reduction of adiposetissue and by improved metabolism due to improved blood flow. Both modesmay be combined in various treatment sequences.

The application of electromagnetic waves may lead to heating of thetissue. Energy flux provided by radiofrequency waves may be in the rangeof 0.001 W/cm² to 1500 W/cm², more preferably in the range of 0.01 W/cm²to 1000 W/cm², most preferably in the range of 0.5 W/cm² to 500 W/cm².

The sum of energy flux density of the radiofrequency waves and theoptical waves applied to the patient during the therapy, where thetherapy means simultaneous, successive or overlap treatment ortreatments, may last up to 120 minutes, more preferably up to 60minutes, most preferably up to 30 minutes, is in the range of 0.03mW·mm-2 and 1,2 W·mm-2, more preferably in the range of 0.05 mW·mm-2 and0.9 W·mm-2, most preferably in the range of 0.01 mW·mm-2 and 0.6 W·mm-2.The energy flux density of optical waves constitutes at least 1%, morepreferably at least 3% and most preferably at least 5% of the sum ofenergy flux density.

In the preferred application the treatment may be started at the momentwhen the target biological structure reaches the predeterminedtemperature. The temperature in the target tissue may be up to 80° C.,more preferably in the range of 37 to 60° C., even more preferably inthe range of 40 to 45° C. The temperature may be adjusted based on theintended use, e.g. adipose tissue reduction, collagen production ormuscle contraction. In an alternative application the intended use maybe coagulation and/or ablation. The temperature in the target biologicalstructure may be measured by invasive method, e.g. using an invasiveprobe; or by contact method, e.g. using thermocouple sensor; or bycontactless method, e.g. using infrared sensor or camera. Thetemperature of the target biological structure may be determined by amathematic method. The sensor for measuring the temperature in thetarget biological structure may be attached to the applicator.

A benefit of the application of magnetic treatment and electromagnetictreatment may be causing an analgesic effect of the application andproviding a possibility of treating a patient with higher sensitivityfor thermal effects induced by electromagnetic treatment, i.e. patientswith any predisposition inducing increased thermal sensitivity. Theanalgesic effect may be induced by magnetic treatment by suitablerepetition rates and it may be induced immediately during the magnetictreatment. The analgesic effect may last up to several hours aftermagnetic treatment. The magnetic flux density of the magnetic treatmentmay preferably reach at least motor-threshold intensity inducing atleast muscle contraction therefore the homogeneity of the thermal fieldmay be significantly enhanced.

Another benefit of application the magnetic treatment may be causing amyorelaxation effect. The magnetic treatment may be applied on spasticmuscle structures to relieve the hypertonus of the muscle and improvingthe blood and/or lymph flow. Therefore relieving the hypertoned musclemay contribute to the analgesic effect and contribute to theacceptability of the treatment by the patient.

The blood and/or lymph flow may be limited in the spastic muscles andthe metabolism may be limited as well, meaning that the risk ofclustering the treated target structures may be higher and possibleadverse events may occur. The recited risks may be eliminated by theused of magnetic treatment.

In one aspect of the invention, the treatment by magnetic field may beapplied to the target structure before the radiofrequency treatment toprepare the target structure for following treatment by radiofrequencyfield. The effect of magnetic treatment may be to induce at least musclecontraction or to treat a muscle structure to increase a muscular tonusof the target structure. Both effects may provide a massage effect forthe structure within the proximity of the target structure hence theblood and/or lymph circulation may be improved to promote localmetabolism. The temperature may be locally increased by the improvedblood flow and the target structure may accept the followingradiofrequency treatment at significantly higher quality. Additionally,the collagen and/or elastin fibers may be remodeled or restored and/orits neogenesis may be improved to provide a younger, smoother, firmerand enhanced skin appearance.

Additionally, previous application may improve acceptability of theelectromagnetic field by increasing the temperature of the skin and thetransmittance of the electromagnetic field may be improved due to lessvalue of skin impedance. Further the radiofrequency may penetrate deepertarget structures relative to treatment without a preceding magnetictreatment of the target structure and/or area.

Another benefit may be releasing the adipose tissue in the muscle bymuscle contraction and/or by temperature increase causing betterliquidity of adipose tissue. Still another benefit of the at leastmuscle contraction may be mechanical breaking large adipose tissue bulksinto smaller bulks which may be easier metabolized and/or the smalleradipose tissue bulks may be removed faster by the lymphatic and/or bloodflow. Due to improved metabolism and/or circulation the cellulite may betreated in a short time and the visual effect on skin appearance may besignificantly enhanced.

In another aspect of the invention, the treatment by magnetic field maybe applied to the target structure simultaneously with theradiofrequency treatment to improve effects of the electromagnetictreatment inducing heat in the target structure.

The simultaneous application of magnetic treatment and radiofrequencytreatment may be in two modes: a first mode may generate the magneticimpulses while radiofrequency treatment is active or another mode maygenerate radiofrequency treatment while the magnetic treatment is not inan active treatment period, i.e. the period of magnetic treatment andradiofrequency treatment alternates. Both modes amplify the resultingeffect of the treatment. Therefore the results may be achieved insignificantly shorter time than the same results achieved by separateapplications of the radio frequency and magnetic treatments.

The simultaneous method of magnetic treatment and radiofrequencytreatment of the target tissue may increase the peak magnetic componentof the entire treatment resulting in improved heating of the targetstructure including containing higher water volume, e.g. skin. Due toincreased temperature of skin, the production and/or remodeling ofcollagen and/or elastin fibers may be improved and the skin may beprovided with a younger, smoother, firmer and enhanced appearance. Theeffect of overheating the muscle may be reduced by the improved bloodflow.

In still another aspect of the invention, the treatment by magneticfield may be applied to the target structure after the treatment byelectromagnetic field to enhance and/or contribute to the effects ofradiofrequency treatment by influencing the target structure by magneticfield.

The magnetic field may treat the target structure to cause at leastmuscle contraction proximate to the target structure to improve bloodflow and provide homogenous temperature distribution at high qualityafter creating a temperature distribution at lower quality byradiofrequency treatment.

All of the methods may be provided by the above recited technicalsolutions. The above mentioned methods may be used separately or in anycombination.

The method may cause the circumferential reduction i.e. a reduction ofthe size of the treated body region. The method may be mostly indicatedfor the regions with cellulite, especially for buttocks, saddlebags,love handles, abdomen, hips, thighs or arms. However, the indication isnot limited to the mentioned regions and the method may be used fortreatment of any other body region.

The at least one applicator may include at least one magnetic fieldgenerating device. The plurality of magnetic field generating devicesmay be positioned in isolated locations of the at least one applicator.Alternatively, the magnetic field generating devices may be positionednext to each other, in an array or matrix, in a pattern or in randomizedlocations of the at least applicator.

The magnetic field generating devices may be positioned and/or moved inthe at least one applicator in one plane; in at least two mutuallytilted planes defined by a convex or concave angle, or perpendicular toeach other; or in at least two parallel planes with the at least onemagnetic field generating device in each parallel plane. The movement ofthe at least one magnetic field generating device may be translationaland/or rotational, constant or accelerated. The movement may follow apredetermined, random or predefined trajectory, such as a pattern, arrayor matrix. The movement of the at least one applicator may be handled insimilar manner as the movement of the at least one magnetic fieldgenerating device. The angles of the planes and/or the movement of theat least one magnetic field generating device may be adjusted by anoperator following the patient's needs. The positioning may be providedby mechanical holder, enabling tilting, distancing and positioningmagnetic field generating device in various planes. In an alternativeembodiment the patient may be positioned in the intersection of themagnetic fields generated by the plurality of magnetic field generatingdevices. In the preferred application the at least one applicator may bemovable and the movement may be circular.

The plurality of magnetic field generating devices may be positionedwithin one applicator having form of mechanical holder. The shape of theapplicator having form of mechanical holder may be adjustable, e.g. theapplicator may include at least one moveable part. In a preferredembodiment the applicator having form of mechanical holder may providespatial arrangement of the energy delivery elements in one axis, twoaxes or three axes and/or provide tilting and/or rotation. Theapplicator having form of mechanical holder may provide fixation of theat least one magnetic field generating device in one position. Themoveable parts may be connected by sliding mechanism and/or by a jointmechanism. An exemplary embodiment of such an applicator may be found inU.S. Pat. No. 9,468,774, incorporated herein by reference. Theapplicator may be adjustable following the body region and/or biologicalstructure.

The present methods may also induce muscle contraction to reduce effectof skin laxity. Skin laxity may be caused by e.g. aging process orincreasing number and/or volume of adipose cells which pulls down theskin by gravity, rapid weight loss or skin stretching during thepregnancy. The muscles may be treated by the induced electric current tocontract. Repetitive contractions may cause the muscles to obtain thetonus and flexibility. Therefore the skin appearance may be enhanced bytreating the flabby muscles. The effect of skin tightening may beachieved. The method also may promote the collagen and elastin fibers inthe layers subtending the epidermis hence the skin may obtain enhancedvisual appearance. The method may be widely applied but not limited toapplication to the regions of neck, breasts, arms or abdomen. The methodmay provide the smoother and younger appearance of the skin to thepatient.

Similar methods of the muscle structure treatment by time-varyingmagnetic field for inducing the at least muscle contraction may be usedfor treatment of wrinkles as well. Wrinkles are results of extrinsic andintrinsic factors. Nowadays, wrinkles are considered to be negativeeffect of natural aging process which decreases the production ofcollagen and elastin fibers and weakens the skin which becomes thinner.As the muscle treatment by the magnetic flux density may induce at leastmuscle contraction, the collagen and elastin fibers neogenesis may beimproved. Additionally, the muscles subtending the treated region may betoned and the skin may obtain a younger and enhanced visual appearance.Therefore, the effect of skin tightening may be achieved.

Wrinkles may be prevented or reduced by practicing facial exerciseswhich may cause a massage effect to the facial tissues, improving bloodand lymph circulation. Additionally, the facial muscles may be relaxedand toned after the exercise. A similar effect as facial exercise may beachieved by non-invasive and/or contactless method of treating thefacial muscles by magnetic flux density. Further additional advantage ofthe present method may be the improvement of restoration of the collagenand elastin fibers, more effective toning and strengthening of thefacial muscles.

The present methods may improve the neogenesis and remodeling ofcollagen fibers in the lips to reach a full, plump and firmerappearance. The magnetic flux density may be applied to the lips by anapplicator. Therefore the lips may become fuller and firmer without anyneed of invasive method such as injection of the synthetic fillers,permanent makeup or the facial implants. The present method may promotethe remodeling and/or neogenesis of collagen fibers in a natural way.Additionally, the collagen is natural substance of the human body whichmay provide the elasticity to the structure.

The present methods may be used for enhancing the visual appearance ofbreasts. Cooper's ligament may be treated, improved and/or firmed by theat least muscle contraction. The treatment may induce the elevation ofthe breast tissue. Additionally, the breast tissue may be treated to bemodified in a shape, wherein the shape includes the size and/or thecontour of the breast tissue. Therefore the visual appearance may beenhanced and breasts may be more attractive for the patient. The presentmethod may be a non-invasive alternative for current aesthetic surgerymethod for the treatment of sagging breast tissue. The present methodmay provide a patient a method of breast visual appearance enhancementwithout surgery. Therefore the method lacks post-surgery complicationssuch as scars, postoperative pain or long recovery period. Varioustreatment protocols may be used.

Following the recited methods the treatment may be but is not limited tocontinuous, pulsed, randomized or burst. The impulse may be but notlimited to monophasic, polyphasic, biphasic and/or static magneticfield. In the preferred application the magnetic impulse may be inbiphasic regime, i.e. it is consisted of two phases, preferably positiveand negative.

Repetition rate and/or magnetic flux density may vary during thetreatment protocol. Further the treatment may include several periods ofdifferent repetition rates, therefore the modulation may be inrepetition rate domain. The treatment may include several periods ofdifferent magnetic flux densities, therefore the modulation may be inmagnetic flux density domain. Alternatively the treatment may includedifferent impulse durations, therefore the modulation may be in impulseduration domain. In yet another approach the treatment may be modulatedby any combinations thereof.

Various envelopes and/or waveforms, e.g. pulse, sinusoidal, rectangular,square, triangular, saw-tooth, trapezoidal, exponential etc. for thepurpose of muscle treatment may also be used, and are not limited torecited shapes.

The values of magnetic flux density and repetition rate are cited inseveral preferred applications since the perception of the treatment issubjective. Nevertheless, the magnetic flux density and repetition ratesare not limited by the recited values. A person skilled in the physicaltherapy is able to repeat and apply the treatment methods adjusting themagnetic flux density and/or repetition rate following the patient'ssensitivity or needs.

The present method is not limited to be used independently. Forenhancing the results the methods may be used in combination with otherconventional non-invasive and/or invasive aesthetic treatment method.

A combined treatment may improve the blood flow, createmicro-disruptions of treated tissue such as adipose cells, and/or createmovement, rotation or polarization of particles by induced currentand/or magnetic field which increase the temperature of treated tissue.The combined treatment may result in increased cell membranepermeability resulting in increased liquefying of clusters of adiposecells and/or lipolysis. The combined treatment highly reduces the riskside effect associated with currently used treatment methods such asoccurrence of e.g. panniculitis or swelling.

An exemplary application of the combined treatment method may useapplication of cold, mechanical treatment, heating and magnetic field.Such application may be cooling the body region and maintaining theadipose cells to the temperature in the range of 15 to −2° C. Coolingmay cool the adipose cells and the adipose cells may be at leastpartially damaged. Further the mechanical treatment may be applied tothe body region to break large clusters to smaller clusters of adiposecells. Further the body region may be heated by e.g. radiofrequencytreatment. The smaller clusters of adipose cells may be heated by theradiofrequency waves more homogenously compared to heating of the largeadipose cells cluster. Finally the time-varying magnetic field may beapplied to the body region. The induced muscle contraction may improveblood and/or lymph flow. The treated adipose cells may be bettermetabolized and/or removed from the treated body region. Further themuscle contraction may metabolize released FFA as a primary energysource.

Another exemplary application may use heating the adipose cells byradiofrequency waves. Alternatively the adipose cells may be heated byultrasound waves or light. Additionally, the cavitation may inducedisruption of the adipose cells. Further the magnetic treatment maycause the muscle contraction increasing blood and/or lymph flow. Themuscle contraction may metabolize released FFA as a primary energysource. Further the mechanical treatment may provide the massage effectfor the treated body region for better regeneration and/or fasterremoving lactate and/or metabolic products. Alternatively the exemplaryapplication may include cooling the body region after applyingmechanical treatment to improve reducing of the adipose cells.

Still another exemplary application may use heating the adipose cells byradiofrequency waves. Alternatively the adipose cells may be heated byultrasound waves or light. Further the shock waves may be applied to thebody region to break large clusters to smaller clusters of adipose cellsand/or improve the blood and/or lymph flow to prepare the treated bodyregion for treatment by magnetic field. The following magnetic field maycause muscle contraction, metabolize released FFA. Finally, the shockwaves may provide the massage effect for the treated body region forbetter regeneration and/or faster removing lactate and/or metabolicproducts.

The combined treatment may be applied for at least 10 seconds. Timeduration of the combined treatment of the body region may be in therange of 1 to 240 minutes, more preferably in the range of 5 to 120minutes, even more preferably 10 to 60 minutes, most preferably up to 30minutes.

Each treatment method of the combined treatment, e.g. magnetic, mechanicor thermal treatment, may be applied immediately after a precedenttreatment method, more preferably around 1 to 24 hours after theprecedent treatment method, e.g. 1, 2, 8 or 20 hours after the precedenttreatment method. The combined treatment may be applied periodically.

Alternatively, the combined treatment may be applied separately, e.g.treatments may alternate in appropriate periods. The period may lastfrom 12 hours to 1 month, more preferably from 1 day to 2 weeks, mostpreferably from 3 days to 1 week.

All the recited methods may be applied to a patient in a non-invasiveand/or contactless way. Therefore the present methods provide aneffective alternative approach of enhancing the visual appearance withno need of invasive treatment or surgery. Further, the visual resultsare appreciable after several treatments. Additionally, the resultsinclude not only the visual appearance enhancement but even theimprovement of the muscle structures, hence the patient feels firmer andtighter. The muscle structures become toned with no need of any diet orspending time by exercising in fitness.

The patient may feel firmer and/or tighter. The skin may be alsotighter. Additionally, adipose tissue reduction may occur. Furthermore,cellulite may be reduced as well.

Alternatively the combined treatment may influence a sport performance.The combined treatment may be used for regeneration after sportperformance and/or for recovering of the athletes after injuries byregenerating the muscles, improving local metabolism, preventing atrophyand/or by selective training of correct motion patterns. Hence a musclememory and/or motion coordination of the athlete may be improved aswell.

All the recited method may be combined together and may be provided invarious sequences to treat various issues during one treatment.Furthermore each application may induce a plurality of treatment effect,e.g. adipose cell reduction and/or reduction of cellulite.

Thus, novel systems and methods have been described. Various changes andsubstitutions may of course be made without departing from the spiritand scope of the invention. The invention, therefore, should not belimited, except by the following claims and their equivalents.

The following U.S. Patent Applications and their combinations with thispatent application are incorporated herein by reference: ProvisionalU.S. Patent Application No. 62/357,679; U.S. patent application Ser. No.15/344,811; Provisional U.S. Patent Application No. 62/587,716;Provisional U.S. Patent Application No. 62/358,417; U.S. patentapplication Ser. No. 15/678,915; Provisional U.S. Patent Application No.62/409,665; U.S. patent application Ser. No. 15478943; U.S. patentapplication Ser. No. 15/786,303.

1-30. (canceled)
 31. A method for increasing apoptotic index, reducingadipose cells, cellulite treatment, and/or circumferential reduction ina patient using a time-varying magnetic field, comprising: placing atleast one magnetic field generating device proximate to a body region ofthe patient; providing energy to the at least one magnetic fieldgenerating device in order to generate at least one time-varyingmagnetic field; and a) applying a magnetic fluence of between 60 and40,000 T·cm² to the body region of abdomen between costae and pelvis; orb) applying a magnetic fluence of between 60 and 40,000 T·cm² to thebody region of a buttock between gluteal sulcus and iliac crest of thepatient; or c) applying a magnetic fluence of between 60 and 40,000T·cm² to the body region of thigh between gluteal sulcus and poplitealfossa of the patient; wherein the at least one time-varying magneticfield is applied to the body region with a magnetic flux densitysufficient to cause a muscle contraction in order to cause a contractionof a muscle.
 32. The method of claim 31 further comprising applying theat least one time-varying magnetic field to the muscle, a neuromuscularplate and/or a nerve innervating the muscle in order to cause arepetitive contraction of at least one muscle of a group including: a)rectus abdominis muscle, external oblique muscle, internal obliquemuscle and/or transversus abdominis; or b) gluteus maximus muscle,gluteus medius muscle and/or gluteus minimus muscle; or c) m. quadricepsfemoris, m. biceps femoris, m. semimembranosus, m. semitendinosus,tensor fascia latae muscle, vastus lateralis muscle, iliotibial muscleand/or m. triceps surae.
 33. The method of claim 31 further comprisingapplying the time-varying magnetic field to the muscle and/or a nerveinnervating the muscle in bursts, wherein each burst consists of firstand second time periods; wherein the first time period consists of aplurality of subsequent magnetic pulses causing the contraction of themuscle and wherein the muscle relaxes during the second time period. 34.The method of claim 31 further comprising charging an energy storagedevice having a capacitance in a range of 5 nF to 100 mF and switching aswitching device in order to discharge the energy storage device to theat least one magnetic field generating device; and applying at least5000 pulses of the time-varying magnetic field to the body region. 35.The method of claim 32 further comprising assembling subsequent magneticpulses into a burst with a treatment duty cycle of at least 1:50,wherein the burst includes a train lasting at least 25 ms.
 36. Themethod of claim 31 further comprising placing an applicator includingthe magnetic field generating device in actual contact with a skin ofthe patient.
 37. The method of claim 36 wherein the magnetic fieldgenerating device has an inductance in a range of 1 nH to 1 H.
 38. Themethod of claim 37 further comprising providing a current pulse of atleast 250 A to the magnetic field generating device.
 39. A method forincreasing apoptotic index, reducing adipose cells, cellulite treatment,a muscle toning, shaping, strengthening effect, and/or a muscle volumeincrease of a patient using a time-varying magnetic field applied to amuscle of the patient comprising: placing a first magnetic fieldgenerating device proximate to a body region including a first muscle;placing a second magnetic field generating device proximate to a bodyregion including a second muscle wherein the second muscle is a pair orcooperating muscle of the first muscle; providing energy to at least oneof the first and/or the second magnetic field generating devices havingan inductance in a range of 1 nH to 1 H in order to generate thetime-varying magnetic field with an impulse duration in a range of 3 to3000 μs; and applying the time-varying magnetic field to the patient'smuscle in the body region including at least one of thigh, saddlebags,buttock, abdomen, hips, love handles, torso and/or arm of the patient inat least two trains wherein each of said trains lasts at least 4 ms andwherein at least one train causes a contraction of the patient's muscleand a relaxation of the patient's muscle follows after the contractionof the patient's muscle.
 40. The method of claim 39 wherein a repetitionrate of magnetic pulses of a first train differs from a repetition rateof magnetic pulses of a second train.
 41. The method of claim 39 furthercomprising applying the time-varying magnetic field to the patient andcausing incomplete and/or complete tetanus contraction of the patient'smuscle.
 42. The method of claim 39 further comprising relaxing thepatient's muscle after the contraction for a period lasting in a rangeof 1 to 15 seconds.
 43. The method of claim 39 further comprisingapplying at least 25 trains to the patient.
 44. The method of claim 39further comprising generating the time-varying magnetic field with awinding magnetic fluence in a range of 40 to 40000 T·cm².
 45. The methodof claim 39 wherein the magnetic field generating device includes a corearea with no winding in a range of 0.01 to 99% of a total magnetic fieldgenerating device surface.
 46. A method for body shaping using atime-varying magnetic field applied to a patient's muscle comprising:placing an applicator including a magnetic field generating device inactual contact with a body region between rib-cage and popliteal fossaof a patient; attaching the applicator by a length adjustablepositioning member; charging an energy storage device; switching aswitching device; discharging the energy storage device to the magneticfield generating device in order to generate the time-varying magneticfield; generating the time-varying magnetic field with a magnetic fluxdensity in a range of 0.1 to 7 Tesla; applying the time-varying magneticfield with a magnetic flux density of a value at least sufficient tocause a contraction of the patient's muscle within the body regionand/or a nerve innervating the patient's muscle in order to cause arepetitive contraction of the patient's muscle; and assembling aplurality of magnetic impulses into a train lasting at least 10 ms;wherein a time difference between two subsequent magnetic impulses isbelow 0.999997 s; wherein the train causes at least one contraction ofthe patient's muscle; wherein the train is followed by a second timeperiod when no contraction of the patient's muscle is caused; andwherein the second time period is longer than the time differencebetween two subsequent magnetic impulses in the train.
 47. The method ofclaim 46 further comprising applying 15 to 25,000 trains to the patientduring one treatment.
 48. The method of claim 47 further comprisingapplying a plurality of trains to the patient wherein at least two ofsaid trains differ in a repetition rate.
 49. The method of claim 46further comprising applying to the patient at least a first train and asecond train each having a different repetition rate of the magneticimpulses, an impulse duration, and/or a train duration.
 50. The methodof claim 49 further comprising generating the time-varying magneticfield with a maximal value of a magnetic flux density derivative in arange of 300 T/s to 800 kT/s.
 51. The method of claim 46 furthercomprising applying a conventional treatment method.
 52. The method ofclaim 46 further comprising applying a conventional treatment method tothe patient no longer than 1 month before or after the treatment bytime-varying magnetic field.
 53. A method for body shaping via acontraction of a muscle using a plurality of time-varying magneticfields applied to a patient, comprising: placing a first applicatorincluding a first magnetic field generating device to the patient;placing a second applicator including a second magnetic field generatingdevice to the patient; charging at least one energy storage devicehaving a capacitance in a range of 5 nF to 100 mF; switching at leastone switching device in order to enable discharging the at least oneenergy storage device to the first and/or the second magnetic fieldgenerating device wherein each magnetic field generating device has aninductance in a range of 1 nH to 1 H; generating a first time-varyingmagnetic field by the first magnetic field generating device andgenerating a second time-varying magnetic field by the second magneticfield generating device; assembling a plurality of impulses of thetime-varying magnetic fields generated by the first and the secondmagnetic field generating devices into a plurality of magnetic pulses,wherein the first time-varying magnetic field and/or the secondtime-varying magnetic field has a magnetic flux density in a range of0.1 to 7 Tesla, a maximal value of a magnetic flux density derivative ina range of 300 T/s to 800 kT/s, a winding magnetic fluence in a range of40 to 40000 T·cm², and wherein each magnetic pulse consists of oneimpulse of the time-varying magnetic field lasting for an impulseduration and no time-varying magnetic field lasting for a first timeperiod; establishing a burst consisting of a second time period and athird time period, wherein the plurality of magnetic pulses is generatedduring the second time period and wherein the third time period followsafter the second time period; applying the bursts to a body region ofthe patient including at least one of thigh, saddlebags, buttock,abdomen, hips, love handle, flanks, bra fat region, torso and/or arm ofthe patient with a repetition rate in a range of 1 to 700 Hz and withthe impulse duration in a range of 10 to 3000 μs; applying at least 5000magnetic pulses to the body region; causing the contraction of themuscle during the second time period; and causing no contraction of themuscle during the third time period.
 54. The method of claim 53 furthercomprising applying the bursts to at least one of a rectus abdominismuscle, external oblique muscle, internal oblique muscle and/ortransversus abdominis muscle.
 55. The method of claim 53 furthercomprising applying the bursts to at least one of a gluteus maximusmuscle, gluteus medius muscle and/or gluteus minimus muscle.
 56. Themethod of claim 55 further comprising applying to the muscle of thepatient 40 to 10000 bursts within one treatment.
 57. The method of claim53 further comprising applying the bursts to at least one of an m.quadriceps femoris, m. biceps femoris, m. semimembranosus, m.semitendinosus, tensor fascia latae muscle, vastus lateralis muscle,iliotibial muscle and/or m. triceps surae.
 58. The method of claim 53further comprising generating at least ten magnetic impulses during thesecond time period.
 59. The method of claim 53 further comprisingapplying the bursts to at least one of an m. biceps brachialis, m.coracobrachialis, m. deltoideus, m. triceps brachii, m. anconeus,muscles of forearm, mm. pectorales minors and/or mm. pectorales majors.60. The method of claim 53 further comprising attaching the first andthe second applicators to the patient by at least one length adjustablepositioning member.